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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01349881
Other study ID # S0820
Secondary ID U10CA037429NCI-2
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date August 23, 2013
Est. completion date February 1, 2032

Study information

Verified date March 2024
Source SWOG Cancer Research Network
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators hypothesize that the combination of eflornithine and sulindac will be effective in reducing a three-year event rate of adenomas and second primary colorectal cancers in patients previously treated for Stages 0 through III colon or rectal cancer.


Description:

The purpose of this study is to assess whether the combination of eflornithine 500 mg and sulindac 150 mg (compared to corresponding placebos) has efficacy against colorectal lesions with respect to high-grade dysplasia, adenomas with villous features, adenomas 1 cm or greater, multiple adenomas, any adenomas >/= 0.3 cm, total advanced colorectal events, or total colorectal events.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 354
Est. completion date February 1, 2032
Est. primary completion date February 1, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - History of Stage 0-III colon or rectal cancer with primary resection 1 year previously - Post-operative colonoscopy and CT scans of chest, abdomen & pelvis showing no evidence of disease - Must not have cardiovascular risk factors including unstable angina, history of myocardial infarction, or cerebrovascular accident, coronary artery bypass surgery, or NY Heart Assoc Class III or IV heart failure. - Patients must not have known uncontrolled hyperlipidemia (defined as LDL-C >/= 190 mg/dL or triglycerides >/= 500 mg/dL within the past 3 years or uncontrolled high blood pressure (systolic blood pressure > 150 mm Hg) within 28 days prior to registration - At least 30 days from completion of adjuvant chemo and RT. - Presence of gastroesophageal reflux disease acceptable if controlled with medications - Not receiving or planning to receive concomitant intravenous corticosteroids on a regular basis,nonsteroidal anti-inflammatory drugs (NSAIDs), nor anticoagulants on a regular predictable intermittent basis. NSAID use must not exceed 10 days per month; Maximum aspirin dose - 100 mg per day or = two 325 mg tablets per week. Inhaled steroids (i.e. for asthma or related conditions) are allowed. - Able to swallow oral medications - Laboratory: WBC = 4.0 x 1000/mcL, platelets = 100,000/mcL and hemoglobin > 11.0 g/dL. (A total WBC = 3.1 x 1000/mcL is allowed for non-Hispanic black males and total WBC = 3.4 x 1000/mcL for non-Hispanic black females. Serum bilirubin = 2.0 mg/dL and AST (SGOT) or ALT(SGPT) = 2 x IULN. Serum creatinine = 1.5 x IULN - Zubrod PS 0-1, 18 years of age or older - Will not participate in any other clinical trial for the treatment or prevention of cancer unless off protocol treatment, on follow-up phase only - Offered opportunity to participate in blood specimen banking Exclusion Criteria: - History of colon resection > 40 cm - Mid-low rectal cancer - Recurrent or metastatic disease - High cardiovascular risk; Uncontrolled hypertension - Planned radiation therapy or additional chemotherapy - Documented history of gastric/duodenal ulcer within last 12 months and/or current treatment or active symptoms of gastric/duodenal ulcer - Known history of familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer, or inflammatory bowel disease - = 30 dB uncorrectable hearing loss for age of any of the five tested frequencies on prestudy audiogram - Known hypersensitivity to sulindac or excipient byproducts. Previous asthma, urticaria, or allergic-type reaction to aspirin or other NSAIDs - Significant medical or psychiatric condition that would preclude study completion (8 years) - No other prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for > 5 years - Pregnant or nursing women. Women/men of reproductive potential must agree to use effective contraception

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Eflornithine placebo & sulindac placebo
Eflornithine placebo 2 tablets PO daily for 3 years. Sulindac placebo 1 tablet PO daily for 3 years
eflornithine & sulindac placebo
Eflornithine two 250 mg tablets PO daily for 3 years. Sulindac placebo 1 tablet PO daily for 3 years.
Eflornithine placebo & sulindac
Eflornithine placebo 2 tablets PO daily for 3 years. Sulindac one 150 mg tablet PO daily for 3 years.
Eflornithine plus sulindac
Eflornithine two 250 mg tablets PO daily for 3 years. Sulindac one 150 mg tablet PO daily for 3 years.

Locations

Country Name City State
United States Pali Momi Medical Center 'Aiea Hawaii
United States Providence Regional Cancer System-Aberdeen Aberdeen Washington
United States Hendrick Medical Center Abilene Texas
United States Jefferson Abington Hospital Abington Pennsylvania
United States Bixby Medical Center Adrian Michigan
United States Hickman Cancer Center Adrian Michigan
United States Riverwood Healthcare Center Aitkin Minnesota
United States Phoebe Putney Memorial Hospital Albany Georgia
United States Lovelace Medical Center-Saint Joseph Square Albuquerque New Mexico
United States New Mexico Oncology Hematology Consultants Albuquerque New Mexico
United States Presbyterian Kaseman Hospital Albuquerque New Mexico
United States University of New Mexico Cancer Center Albuquerque New Mexico
United States Lehigh Valley Hospital-Cedar Crest Allentown Pennsylvania
United States Community Hospital of Anaconda Anaconda Montana
United States Cancer Care Center at Island Hospital Anacortes Washington
United States Kaiser Permanente-Anaheim Anaheim California
United States Alaska Breast Care and Surgery LLC Anchorage Alaska
United States Alaska Oncology and Hematology LLC Anchorage Alaska
United States Alaska Regional Hospital Anchorage Alaska
United States Alaska Women's Cancer Care Anchorage Alaska
United States Anchorage Associates in Radiation Medicine Anchorage Alaska
United States Katmai Oncology Group Anchorage Alaska
United States Providence Alaska Medical Center Anchorage Alaska
United States AnMed Health Cancer Center Anderson South Carolina
United States Saint Joseph Mercy Hospital Ann Arbor Michigan
United States University of Michigan Comprehensive Cancer Center Ann Arbor Michigan
United States Langlade Hospital and Cancer Center Antigo Wisconsin
United States Kaiser Permanente-Deer Valley Medical Center Antioch California
United States Mission Hope Medical Oncology - Arroyo Grande Arroyo Grande California
United States Duluth Clinic Ashland Ashland Wisconsin
United States Emory Saint Joseph's Hospital Atlanta Georgia
United States Emory University Hospital Midtown Atlanta Georgia
United States Emory University Hospital/Winship Cancer Institute Atlanta Georgia
United States Hematology Oncology Associates of Central New York-Auburn Auburn New York
United States MultiCare Auburn Medical Center Auburn Washington
United States Sutter Auburn Faith Hospital Auburn California
United States Sutter Cancer Centers Radiation Oncology Services-Auburn Auburn California
United States Rocky Mountain Cancer Centers-Aurora Aurora Colorado
United States Rocky Mountain Regional VA Medical Center Aurora Colorado
United States Rush - Copley Medical Center Aurora Illinois
United States The Medical Center of Aurora Aurora Colorado
United States University of Colorado Hospital Aurora Colorado
United States Virginia Mason Bainbridge Island Medical Center Bainbridge Island Washington
United States Saint Alphonsus Medical Center-Baker City Baker City Oregon
United States Kaiser Permanente-Baldwin Park Baldwin Park California
United States Kaiser Permanente-Woodlawn Medical Center Baltimore Maryland
United States Sinai Hospital of Baltimore Baltimore Maryland
United States University of Maryland/Greenebaum Cancer Center Baltimore Maryland
United States Flaget Memorial Hospital Bardstown Kentucky
United States Louisiana Hematology Oncology Associates LLC Baton Rouge Louisiana
United States LSU Health Baton Rouge-North Clinic Baton Rouge Louisiana
United States Mary Bird Perkins Cancer Center Baton Rouge Louisiana
United States Medical Center of Baton Rouge Baton Rouge Louisiana
United States Ochsner Health Center-Summa Baton Rouge Louisiana
United States Ochsner High Grove Baton Rouge Louisiana
United States Our Lady of the Lake Physicians Group - Medical Oncology Baton Rouge Louisiana
United States Bronson Battle Creek Battle Creek Michigan
United States McLaren Cancer Institute-Bay City Bay City Michigan
United States Cleveland Clinic Cancer Center Beachwood Beachwood Ohio
United States UHHS-Chagrin Highlands Medical Center Beachwood Ohio
United States Beaufort Memorial Hospital Beaufort South Carolina
United States Indu and Raj Soin Medical Center Beavercreek Ohio
United States UM Upper Chesapeake Medical Center Bel Air Maryland
United States Overlake Medical Center Bellevue Washington
United States Kaiser Permanente-Bellflower Bellflower California
United States PeaceHealth Saint Joseph Medical Center Bellingham Washington
United States Gaston Hematology and Oncology Associates-Belmont Belmont North Carolina
United States Strecker Cancer Center-Belpre Belpre Ohio
United States Sanford Joe Lueken Cancer Center Bemidji Minnesota
United States Saint Charles Health System Bend Oregon
United States Alta Bates Summit Medical Center-Herrick Campus Berkeley California
United States Central Vermont Medical Center/National Life Cancer Treatment Berlin Vermont
United States Mac Neal Hospital Berwyn Illinois
United States Lehigh Valley Hospital - Muhlenberg Bethlehem Pennsylvania
United States University of Iowa Healthcare Cancer Services Quad Cities Bettendorf Iowa
United States Beverly Hospital Beverly Massachusetts
United States Spectrum Health Big Rapids Hospital Big Rapids Michigan
United States Billings Clinic Cancer Center Billings Montana
United States Saint Vincent Frontier Cancer Center Billings Montana
United States Saint Vincent Healthcare Billings Montana
United States University of Alabama at Birmingham Cancer Center Birmingham Alabama
United States Sanford Bismarck Medical Center Bismarck North Dakota
United States Illinois CancerCare-Bloomington Bloomington Illinois
United States Saint Joseph Medical Center Bloomington Illinois
United States Saint Joseph's/Candler - Bluffton Campus Bluffton South Carolina
United States Prisma Health Cancer Institute - Spartanburg Boiling Springs South Carolina
United States Saint Alphonsus Cancer Care Center-Boise Boise Idaho
United States Saint Luke's Cancer Institute - Boise Boise Idaho
United States Parkland Health Center-Bonne Terre Bonne Terre Missouri
United States Boulder Community Foothills Hospital Boulder Colorado
United States Boulder Community Hospital Boulder Colorado
United States Rocky Mountain Cancer Centers-Boulder Boulder Colorado
United States Toledo Clinic Cancer Centers-Bowling Green Bowling Green Ohio
United States Bozeman Deaconess Hospital Bozeman Montana
United States Essentia Health Saint Joseph's Medical Center Brainerd Minnesota
United States Harrison HealthPartners Hematology and Oncology-Bremerton Bremerton Washington
United States Harrison Medical Center Bremerton Washington
United States Bridgeport Hospital Bridgeport Connecticut
United States Saint Joseph Mercy Brighton Brighton Michigan
United States Steward Saint Elizabeth's Medical Center Brighton Massachusetts
United States Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton Michigan
United States Saint Joseph Regional Cancer Center Bryan Texas
United States Bryn Mawr Hospital Bryn Mawr Pennsylvania
United States Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California
United States Highline Medical Center-Main Campus Burien Washington
United States Kaiser Permanente-Burke Medical Center Burke Virginia
United States Mills-Peninsula Medical Center Burlingame California
United States University of Vermont and State Agricultural College Burlington Vermont
United States University of Vermont Medical Center Burlington Vermont
United States Fairview Ridges Hospital Burnsville Minnesota
United States Saint James Community Hospital and Cancer Treatment Center Butte Montana
United States Saint Alphonsus Cancer Care Center-Caldwell Caldwell Idaho
United States Cooper Hospital University Medical Center Camden New Jersey
United States Sutter Cancer Centers Radiation Oncology Services-Cameron Park Cameron Park California
United States Aultman Health Foundation Canton Ohio
United States Cleveland Clinic Mercy Hospital Canton Ohio
United States Illinois CancerCare-Canton Canton Illinois
United States Saint Joseph Mercy Canton Canton Michigan
United States Trinity Health IHA Medical Group Hematology Oncology - Canton Canton Michigan
United States Saint Francis Medical Center Cape Girardeau Missouri
United States Southeast Cancer Center Cape Girardeau Missouri
United States Memorial Hospital of Carbondale Carbondale Illinois
United States Caro Cancer Center Caro Michigan
United States SIH Cancer Institute Carterville Illinois
United States Illinois CancerCare-Carthage Carthage Illinois
United States Rocky Mountain Oncology Casper Wyoming
United States East Bay Radiation Oncology Center Castro Valley California
United States Eden Hospital Medical Center Castro Valley California
United States Valley Medical Oncology Consultants-Castro Valley Castro Valley California
United States Mercy Hospital Cedar Rapids Iowa
United States Oncology Associates at Mercy Medical Center Cedar Rapids Iowa
United States Physicians' Clinic of Iowa PC Cedar Rapids Iowa
United States Dayton Physicians LLC-Miami Valley South Centerville Ohio
United States Miami Valley Hospital South Centerville Ohio
United States Centralia Oncology Clinic Centralia Illinois
United States Providence Regional Cancer System-Centralia Centralia Washington
United States Cancer Center of Kansas - Chanute Chanute Kansas
United States Geauga Hospital Chardon Ohio
United States Bon Secours Saint Francis Hospital Charleston South Carolina
United States Charleston Oncology - Roper Charleston South Carolina
United States Charleston Oncology - Saint Francis Charleston South Carolina
United States Lowcountry Hematology Oncology PA-North Charleston Charleston South Carolina
United States Lowcountry Hematology Oncology PA-West Ashley Charleston South Carolina
United States Roper Hospital Charleston South Carolina
United States Novant Health Carolina Surgical - Randolph Charlotte North Carolina
United States Novant Health Presbyterian Medical Center Charlotte North Carolina
United States Oncology Specialists of Charlotte Charlotte North Carolina
United States Southern Oncology Specialists-Charlotte Charlotte North Carolina
United States Memorial Hospital Chattanooga Tennessee
United States Saint Joseph Mercy Chelsea Chelsea Michigan
United States Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea Michigan
United States Cheyenne Regional Medical Center-West Cheyenne Wyoming
United States Rush University Medical Center Chicago Illinois
United States UChicago Medicine Comprehensive Cancer Center - Saint Joseph Hospital Chicago Illinois
United States Weiss Memorial Hospital Chicago Illinois
United States Enloe Medical Center Chico California
United States Adena Regional Medical Center Chillicothe Ohio
United States Marshfield Clinic-Chippewa Center Chippewa Falls Wisconsin
United States Bethesda North Hospital Cincinnati Ohio
United States Good Samaritan Hospital - Cincinnati Cincinnati Ohio
United States Oncology Hematology Care Inc-Anderson Cincinnati Ohio
United States Oncology Hematology Care Inc-Blue Ash Cincinnati Ohio
United States Oncology Hematology Care Inc-Eden Park Cincinnati Ohio
United States Oncology Hematology Care Inc-Kenwood Cincinnati Ohio
United States Oncology Hematology Care Inc-Mercy West Cincinnati Ohio
United States The Christ Hospital Cincinnati Ohio
United States TriHealth Cancer Institute-Anderson Cincinnati Ohio
United States TriHealth Cancer Institute-Westside Cincinnati Ohio
United States Clackamas Radiation Oncology Center Clackamas Oregon
United States Providence Cancer Institute Clackamas Clinic Clackamas Oregon
United States Hematology Oncology Consultants-Clarkston Clarkston Michigan
United States Newland Medical Associates-Clarkston Clarkston Michigan
United States Case Western Reserve University Cleveland Ohio
United States Cleveland Clinic Cancer Center/Fairview Hospital Cleveland Ohio
United States Cleveland Clinic Foundation Cleveland Ohio
United States Southeastern Medical Oncology Center-Clinton Clinton North Carolina
United States Medical Oncology and Hematology Associates-West Des Moines Clive Iowa
United States Mercy Cancer Center-West Lakes Clive Iowa
United States University Oncology Associates Clovis California
United States Big Horn Basin Cancer Center Cody Wyoming
United States Billings Clinic-Cody Cody Wyoming
United States Kootenai Health - Coeur d'Alene Coeur d'Alene Idaho
United States Main Line Health Center-Collegeville Collegeville Pennsylvania
United States Baptist Memorial Hospital and Cancer Center-Collierville Collierville Tennessee
United States Penrose-Saint Francis Healthcare Colorado Springs Colorado
United States Rocky Mountain Cancer Centers-Penrose Colorado Springs Colorado
United States UCHealth Memorial Hospital Central Colorado Springs Colorado
United States Columbus Oncology and Hematology Associates Inc Columbus Ohio
United States Doctors Hospital Columbus Ohio
United States Grant Medical Center Columbus Ohio
United States John B Amos Cancer Center Columbus Georgia
United States Mount Carmel East Hospital Columbus Ohio
United States Mount Carmel Health Center West Columbus Ohio
United States Ohio State University Comprehensive Cancer Center Columbus Ohio
United States Riverside Methodist Hospital Columbus Ohio
United States The Mark H Zangmeister Center Columbus Ohio
United States New Hampshire Oncology Hematology PA-Concord Concord New Hampshire
United States Mercy Hospital Coon Rapids Minnesota
United States Bay Area Hospital Coos Bay Oregon
United States Commonwealth Cancer Center-Corbin Corbin Kentucky
United States The West Clinic - Corinth Corinth Mississippi
United States UC Irvine Health Cancer Center-Newport Costa Mesa California
United States Alegent Health Mercy Hospital Council Bluffs Iowa
United States Greater Regional Medical Center Creston Iowa
United States Oncology Hematology Care Inc-Crestview Crestview Hills Kentucky
United States Michiana Hematology Oncology PC-Crown Point Crown Point Indiana
United States UPMC Western Maryland Cumberland Maryland
United States Baylor University Medical Center Dallas Texas
United States Parkland Memorial Hospital Dallas Texas
United States UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas
United States Carle on Vermilion Danville Illinois
United States Geisinger Medical Center Danville Pennsylvania
United States Sutter Davis Hospital Davis California
United States Dayton Physician LLC-Miami Valley Hospital North Dayton Ohio
United States Good Samaritan Hospital - Dayton Dayton Ohio
United States Grandview Hospital Dayton Ohio
United States Miami Valley Hospital Dayton Ohio
United States Miami Valley Hospital North Dayton Ohio
United States Beaumont Hospital - Dearborn Dearborn Michigan
United States Decatur Memorial Hospital Decatur Illinois
United States Essentia Health - Deer River Clinic Deer River Minnesota
United States Delaware Health Center-Grady Cancer Center Delaware Ohio
United States Delaware Radiation Oncology Delaware Ohio
United States Grady Memorial Hospital Delaware Ohio
United States Colorado Blood Cancer Institute Denver Colorado
United States Porter Adventist Hospital Denver Colorado
United States Presbyterian - Saint Lukes Medical Center - Health One Denver Colorado
United States Rocky Mountain Cancer Centers-Midtown Denver Colorado
United States Rocky Mountain Cancer Centers-Rose Denver Colorado
United States Rose Medical Center Denver Colorado
United States SCL Health Saint Joseph Hospital Denver Colorado
United States Smilow Cancer Hospital-Derby Care Center Derby Connecticut
United States Iowa Lutheran Hospital Des Moines Iowa
United States Iowa Methodist Medical Center Des Moines Iowa
United States Medical Oncology and Hematology Associates-Des Moines Des Moines Iowa
United States Mercy Medical Center - Des Moines Des Moines Iowa
United States Mission Cancer and Blood - Laurel Des Moines Iowa
United States Ascension Saint John Hospital Detroit Michigan
United States Wayne State University/Karmanos Cancer Institute Detroit Michigan
United States Cancer Center of Kansas - Dodge City Dodge City Kansas
United States City of Hope Comprehensive Cancer Center Duarte California
United States Columbus Oncology and Hematology Associates Dublin Ohio
United States Dublin Methodist Hospital Dublin Ohio
United States Epic Care-Dublin Dublin California
United States Kaiser Permanente Dublin Dublin California
United States Essentia Health Cancer Center Duluth Minnesota
United States Essentia Health Saint Mary's Medical Center Duluth Minnesota
United States Miller-Dwan Hospital Duluth Minnesota
United States Mercy Medical Center Durango Colorado
United States Southwest Oncology PC Durango Colorado
United States Prisma Health Cancer Institute - Easley Easley South Carolina
United States Great Lakes Cancer Management Specialists-Doctors Park East China Township Michigan
United States Pocono Medical Center East Stroudsburg Pennsylvania
United States Hematology Oncology Associates of Central New York-East Syracuse East Syracuse New York
United States Easton Hospital Easton Pennsylvania
United States Marshfield Clinic Cancer Center at Sacred Heart Eau Claire Wisconsin
United States Marshfield Medical Center-EC Cancer Center Eau Claire Wisconsin
United States Saint Elizabeth Healthcare Edgewood Edgewood Kentucky
United States Fairview Southdale Hospital Edina Minnesota
United States Swedish Cancer Institute-Edmonds Edmonds Washington
United States Carle Physician Group-Effingham Effingham Illinois
United States Crossroads Cancer Center Effingham Illinois
United States Cancer Center of Kansas - El Dorado El Dorado Kansas
United States Elkhart Clinic Elkhart Indiana
United States Elkhart General Hospital Elkhart Indiana
United States Michiana Hematology Oncology PC-Elkhart Elkhart Indiana
United States Christiana Care - Union Hospital Elkton Maryland
United States Arnot Ogden Medical Center/Falck Cancer Center Elmira New York
United States Hematology Oncology Center Incorporated Elyria Ohio
United States Mercy Cancer Center-Elyria Elyria Ohio
United States Bay Area Breast Surgeons Inc Emeryville California
United States Epic Care Partners in Cancer Care Emeryville California
United States Walter Knox Memorial Hospital Emmett Idaho
United States Newman Regional Health Emporia Kansas
United States Mountain Blue Cancer Care Center - Swedish Englewood Colorado
United States Swedish Medical Center Englewood Colorado
United States Saint Elizabeth Hospital Enumclaw Washington
United States Green Bay Oncology - Escanaba Escanaba Michigan
United States Illinois CancerCare-Eureka Eureka Illinois
United States Providence Regional Cancer Partnership Everett Washington
United States Exeter Hospital Exeter New Hampshire
United States Main Line Health Center-Exton Exton Pennsylvania
United States Fairbanks Memorial Hospital Fairbanks Alaska
United States Oncology Hematology Care Inc-Healthplex Fairfield Ohio
United States Smilow Cancer Hospital Care Center-Fairfield Fairfield Connecticut
United States Essentia Health Cancer Center-South University Clinic Fargo North Dakota
United States Sanford Broadway Medical Center Fargo North Dakota
United States Sanford Clinic North-Fargo Fargo North Dakota
United States Sanford Roger Maris Cancer Center Fargo North Dakota
United States Beaumont Hospital - Farmington Hills Farmington Hills Michigan
United States Weisberg Cancer Treatment Center Farmington Hills Michigan
United States Saint Francis Hospital Federal Way Washington
United States Virginia Mason Federal Way Medical Center Federal Way Washington
United States Lake Region Healthcare Corporation-Cancer Care Fergus Falls Minnesota
United States Armes Family Cancer Center Findlay Ohio
United States Blanchard Valley Hospital Findlay Ohio
United States Orion Cancer Care Findlay Ohio
United States Genesee Cancer and Blood Disease Treatment Center Flint Michigan
United States Genesee Hematology Oncology PC Flint Michigan
United States Genesys Hurley Cancer Institute Flint Michigan
United States Hurley Medical Center Flint Michigan
United States McLaren Cancer Institute-Flint Flint Michigan
United States Singh and Arora Hematology Oncology PC Flint Michigan
United States Kaiser Permanente-Fontana Fontana California
United States Poudre Valley Hospital Fort Collins Colorado
United States Eisenhower Army Medical Center Fort Gordon Georgia
United States Brooke Army Medical Center Fort Sam Houston Texas
United States Cancer Center of Kansas - Fort Scott Fort Scott Kansas
United States Saint Elizabeth Fort Thomas Fort Thomas Kentucky
United States Atrium Medical Center-Middletown Regional Hospital Franklin Ohio
United States Dayton Physicians LLC-Atrium Franklin Ohio
United States Fredericksburg Oncology Inc Fredericksburg Virginia
United States Kaiser Permanente-Fremont Fremont California
United States Valley Medical Oncology Consultants-Fremont Fremont California
United States Kaiser Permanente-Fresno Fresno California
United States Unity Hospital Fridley Minnesota
United States Saint Luke's Cancer Institute - Fruitland Fruitland Idaho
United States Gibbs Cancer Center-Gaffney Gaffney South Carolina
United States Central Ohio Breast and Endocrine Surgery Gahanna Ohio
United States Northeast Georgia Medical Center-Gainesville Gainesville Georgia
United States Kaiser Permanente-Gaithersburg Medical Center Gaithersburg Maryland
United States Illinois CancerCare-Galesburg Galesburg Illinois
United States Western Illinois Cancer Treatment Center Galesburg Illinois
United States Saint Catherine Hospital Garden City Kansas
United States CaroMont Regional Medical Center Gastonia North Carolina
United States Gaston Hematology and Oncology Associates Gastonia North Carolina
United States Northwestern Medicine Cancer Center Delnor Geneva Illinois
United States The West Clinic - Wolf River Germantown Tennessee
United States MultiCare Gig Harbor Medical Park Gig Harbor Washington
United States Tacoma/Valley Radiation Oncology Centers-Gig Harbor Gig Harbor Washington
United States Banner MD Anderson Cancer Center Gilbert Arizona
United States Glens Falls Hospital Glens Falls New York
United States Addison Gilbert Hospital Gloucester Massachusetts
United States Mountain Blue Cancer Care Center Golden Colorado
United States Southeastern Medical Oncology Center-Goldsboro Goldsboro North Carolina
United States Wayne Memorial Hospital Goldsboro North Carolina
United States Altru Cancer Center Grand Forks North Dakota
United States CHI Health Saint Francis Grand Island Nebraska
United States Mercy Health Saint Mary's Grand Rapids Michigan
United States Spectrum Health at Butterworth Campus Grand Rapids Michigan
United States Central Care Cancer Center - Great Bend Great Bend Kansas
United States Saint Rose Ambulatory and Surgery Center Great Bend Kansas
United States Benefis Healthcare- Sletten Cancer Institute Great Falls Montana
United States Great Falls Clinic Great Falls Montana
United States North Colorado Medical Center Greeley Colorado
United States Bellin Memorial Hospital Green Bay Wisconsin
United States Green Bay Oncology at Saint Vincent Hospital Green Bay Wisconsin
United States Green Bay Oncology Limited at Saint Mary's Hospital Green Bay Wisconsin
United States Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay Wisconsin
United States Saint Vincent Hospital Cancer Center Green Bay Green Bay Wisconsin
United States Dayton Physicians LLC-Wayne Greenville Ohio
United States Greenville Health System Cancer Institute-Andrews Greenville South Carolina
United States Prisma Health Cancer Institute - Butternut Greenville South Carolina
United States Prisma Health Cancer Institute - Eastside Greenville South Carolina
United States Prisma Health Cancer Institute - Faris Greenville South Carolina
United States Prisma Health Greenville Memorial Hospital Greenville South Carolina
United States Saint Francis Hospital Greenville South Carolina
United States Wayne Hospital Greenville Ohio
United States Greenwich Hospital Greenwich Connecticut
United States Smilow Cancer Hospital Care Center at Greenwich Greenwich Connecticut
United States Self Regional Healthcare Greenwood South Carolina
United States Rocky Mountain Cancer Centers-Greenwood Village Greenwood Village Colorado
United States Gibbs Cancer Center-Pelham Greer South Carolina
United States Prisma Health Cancer Institute - Greer Greer South Carolina
United States Baptist Cancer Center-Grenada Grenada Mississippi
United States Academic Hematology Oncology Specialists Grosse Pointe Woods Michigan
United States Great Lakes Cancer Management Specialists-Van Elslander Cancer Center Grosse Pointe Woods Michigan
United States Michigan Breast Specialists-Grosse Pointe Woods Grosse Pointe Woods Michigan
United States Mount Carmel Grove City Hospital Grove City Ohio
United States Smilow Cancer Hospital Care Center - Guiford Guilford Connecticut
United States Kaiser Permanente - Harbor City Harbor City California
United States Smilow Cancer Hospital Care Center at Saint Francis Hartford Connecticut
United States Ingalls Memorial Hospital Harvey Illinois
United States HaysMed University of Kansas Health System Hays Kansas
United States Geisinger Medical Center-Cancer Center Hazleton Hazleton Pennsylvania
United States Lehigh Valley Hospital-Hazleton Hazleton Pennsylvania
United States Saint Peter's Community Hospital Helena Montana
United States Cancer and Blood Specialists-Henderson Henderson Nevada
United States Comprehensive Cancer Centers of Nevada - Henderson Henderson Nevada
United States Comprehensive Cancer Centers of Nevada-Horizon Ridge Henderson Nevada
United States Comprehensive Cancer Centers of Nevada-Southeast Henderson Henderson Nevada
United States GenesisCare USA - Henderson Henderson Nevada
United States Las Vegas Cancer Center-Henderson Henderson Nevada
United States OptumCare Cancer Care at Seven Hills Henderson Nevada
United States AdventHealth Hendersonville Hendersonville North Carolina
United States Hendersonville Hematology and Oncology at Pardee Hendersonville North Carolina
United States Margaret R Pardee Memorial Hospital Hendersonville North Carolina
United States Essentia Health Hibbing Clinic Hibbing Minnesota
United States South Carolina Cancer Specialists PC Hilton Head Island South Carolina
United States Edward Hines Jr VA Hospital Hines Illinois
United States Pulmonary Medicine Center of Chattanooga-Hixson Hixson Tennessee
United States Hawaii Cancer Care Inc - Waterfront Plaza Honolulu Hawaii
United States Hawaii Cancer Care Inc-Liliha Honolulu Hawaii
United States Kaiser Permanente Moanalua Medical Center Honolulu Hawaii
United States Kapiolani Medical Center for Women and Children Honolulu Hawaii
United States Queen's Cancer Center - Kuakini Honolulu Hawaii
United States Queen's Medical Center Honolulu Hawaii
United States Straub Clinic and Hospital Honolulu Hawaii
United States The Cancer Center of Hawaii-Liliha Honolulu Hawaii
United States Tripler Army Medical Center Honolulu Hawaii
United States University of Hawaii Cancer Center Honolulu Hawaii
United States CHI Saint Vincent Cancer Center Hot Springs Hot Springs Arkansas
United States Mary Bird Perkins Cancer Center - Houma Houma Louisiana
United States M D Anderson Cancer Center Houston Texas
United States Novant Health Cancer Institute - Huntersville Huntersville North Carolina
United States Southern Oncology Specialists-Huntersville Huntersville North Carolina
United States Saint Mary's Medical Center Huntington West Virginia
United States Hutchinson Area Health Care Hutchinson Minnesota
United States Hutchinson Regional Medical Center Hutchinson Kansas
United States Cancer Center of Kansas-Independence Independence Kansas
United States Centerpoint Medical Center LLC Independence Missouri
United States Cleveland Clinic Cancer Center Independence Independence Ohio
United States Lallie Kemp Regional Medical Center Independence Louisiana
United States Franciscan Health Indianapolis Indianapolis Indiana
United States University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa
United States Green Bay Oncology - Iron Mountain Iron Mountain Michigan
United States Kaiser Permanente-Irvine Irvine California
United States Swedish Cancer Institute-Issaquah Issaquah Washington
United States Allegiance Health Jackson Michigan
United States University of Mississippi Medical Center Jackson Mississippi
United States Southeastern Medical Oncology Center-Jacksonville Jacksonville North Carolina
United States Boston Veteran's Affairs Medical Center Jamaica Plain Massachusetts
United States Capital Region Southwest Campus Jefferson City Missouri
United States NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro Jonesboro Arkansas
United States Freeman Health System Joplin Missouri
United States Castle Medical Center Kailua Hawaii
United States Borgess Medical Center Kalamazoo Michigan
United States Bronson Methodist Hospital Kalamazoo Michigan
United States West Michigan Cancer Center Kalamazoo Michigan
United States Kalispell Regional Medical Center Kalispell Montana
United States Heartland Hematology and Oncology Associates Incorporated Kansas City Missouri
United States Kansas City Veterans Affairs Medical Center Kansas City Missouri
United States North Kansas City Hospital Kansas City Missouri
United States Providence Medical Center Kansas City Kansas
United States Research Medical Center Kansas City Missouri
United States Saint Luke's Hospital of Kansas City Kansas City Missouri
United States The University of Kansas Cancer Center-South Kansas City Missouri
United States Truman Medical Centers Kansas City Missouri
United States University of Kansas Cancer Center Kansas City Kansas
United States University of Kansas Cancer Center - North Kansas City Missouri
United States University of Kansas Cancer Center-West Kansas City Kansas
United States CHI Health Good Samaritan Kearney Nebraska
United States Heartland Hematology and Oncology Kearney Nebraska
United States Ochsner Medical Center Kenner Kenner Louisiana
United States Kadlec Clinic Hematology and Oncology Kennewick Washington
United States Northwest Cancer Clinic Kennewick Washington
United States First Dayton Cancer Care Kettering Ohio
United States Greater Dayton Cancer Center Kettering Ohio
United States Kettering Medical Center Kettering Ohio
United States Illinois CancerCare-Kewanee Clinic Kewanee Illinois
United States Cancer Center of Kansas-Kingman Kingman Kansas
United States Seattle Cancer Care Alliance at EvergreenHealth Kirkland Washington
United States University of Tennessee - Knoxville Knoxville Tennessee
United States Community Howard Regional Health Kokomo Indiana
United States Gundersen Lutheran Medical Center La Crosse Wisconsin
United States UC San Diego Moores Cancer Center La Jolla California
United States IU Health La Porte Hospital La Porte Indiana
United States Providence Regional Cancer System-Lacey Lacey Washington
United States LRGHealthcare-Lakes Region General Hospital Laconia New Hampshire
United States UCI Health Laguna Hills Laguna Hills California
United States Northwell Health/Center for Advanced Medicine Lake Success New York
United States Rocky Mountain Cancer Centers-Lakewood Lakewood Colorado
United States Saint Anthony Hospital Lakewood Colorado
United States Saint Clare Hospital Lakewood Washington
United States Fairfield Medical Center Lancaster Ohio
United States Lancaster Radiation Oncology Lancaster Ohio
United States Karmanos Cancer Institute at McLaren Greater Lansing Lansing Michigan
United States Sparrow Hospital Lansing Michigan
United States McLaren Cancer Institute-Lapeer Region Lapeer Michigan
United States Kaiser Permanente - Largo Medical Center Largo Maryland
United States Cancer and Blood Specialists-Shadow Las Vegas Nevada
United States Cancer and Blood Specialists-Tenaya Las Vegas Nevada
United States Cancer Therapy and Integrative Medicine Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada - Northwest Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada-Summerlin Las Vegas Nevada
United States GenesisCare USA - Fort Apache Las Vegas Nevada
United States GenesisCare USA - Las Vegas Las Vegas Nevada
United States GenesisCare USA - Vegas Tenaya Las Vegas Nevada
United States HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills Las Vegas Nevada
United States HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway Las Vegas Nevada
United States HealthCare Partners Medical Group Oncology/Hematology-San Martin Las Vegas Nevada
United States HealthCare Partners Medical Group Oncology/Hematology-Tenaya Las Vegas Nevada
United States Las Vegas Cancer Center-Medical Center Las Vegas Nevada
United States OptumCare Cancer Care at Charleston Las Vegas Nevada
United States OptumCare Cancer Care at Fort Apache Las Vegas Nevada
United States OptumCare Cancer Care at MountainView Las Vegas Nevada
United States Radiation Oncology Centers of Nevada Central Las Vegas Nevada
United States Radiation Oncology Centers of Nevada Southeast Las Vegas Nevada
United States University Medical Center of Southern Nevada Las Vegas Nevada
United States Lawrence Memorial Hospital Lawrence Kansas
United States Cancer Centers of Southwest Oklahoma Research Lawton Oklahoma
United States Saint Luke's East - Lee's Summit Lee's Summit Missouri
United States University of Kansas Cancer Center - Lee's Summit Lee's Summit Missouri
United States Kansas Institute of Medicine Cancer and Blood Center Lenexa Kansas
United States Minimally Invasive Surgery Hospital Lenexa Kansas
United States Beebe Medical Center Lewes Delaware
United States Geisinger Medical Oncology-Lewisburg Lewisburg Pennsylvania
United States Central Maine Medical Center Lewiston Maine
United States Saint Joseph Regional Medical Center Lewiston Idaho
United States Lewistown Hospital Lewistown Pennsylvania
United States Saint Joseph Hospital East Lexington Kentucky
United States Saint Joseph Radiation Oncology Resource Center Lexington Kentucky
United States University of Kentucky/Markey Cancer Center Lexington Kentucky
United States Cancer Center of Kansas-Liberal Liberal Kansas
United States Liberty Radiation Oncology Center Liberty Missouri
United States Wilcox Memorial Hospital and Kauai Medical Clinic Lihue Hawaii
United States Lima Memorial Hospital Lima Ohio
United States Saint Rita's Medical Center Lima Ohio
United States Nebraska Cancer Research Center Lincoln Nebraska
United States Nebraska Hematology and Oncology Lincoln Nebraska
United States Saint Elizabeth Regional Medical Center Lincoln Nebraska
United States University of Arkansas for Medical Sciences Little Rock Arkansas
United States Littleton Adventist Hospital Littleton Colorado
United States Rocky Mountain Cancer Centers-Littleton Littleton Colorado
United States Hematology Oncology Associates of Central New York-Liverpool Liverpool New York
United States Hope Cancer Clinic Livonia Michigan
United States Trinity Health Saint Mary Mercy Livonia Hospital Livonia Michigan
United States Loma Linda University Medical Center Loma Linda California
United States Veterans Affairs Loma Linda Healthcare System Loma Linda California
United States Saint Joseph London London Kentucky
United States Rocky Mountain Cancer Centers-Sky Ridge Lone Tree Colorado
United States Sky Ridge Medical Center Lone Tree Colorado
United States Longmont United Hospital Longmont Colorado
United States Rocky Mountain Cancer Centers-Longmont Longmont Colorado
United States PeaceHealth Saint John Medical Center Longview Washington
United States Cedars Sinai Medical Center Los Angeles California
United States Kaiser Permanente Los Angeles Medical Center Los Angeles California
United States Kaiser Permanente West Los Angeles Los Angeles California
United States Los Angeles County-USC Medical Center Los Angeles California
United States USC / Norris Comprehensive Cancer Center Los Angeles California
United States Jewish Hospital Louisville Kentucky
United States Saints Mary and Elizabeth Hospital Louisville Kentucky
United States UofL Health Medical Center Northeast Louisville Kentucky
United States McKee Medical Center Loveland Colorado
United States Covenant Medical Center-Lakeside Lubbock Texas
United States Virginia Mason Lynnwood Medical Center Lynnwood Washington
United States Great Lakes Cancer Management Specialists-Macomb Medical Campus Macomb Michigan
United States Illinois CancerCare-Macomb Macomb Illinois
United States Michigan Breast Specialists-Macomb Township Macomb Michigan
United States Solinsky Center for Cancer Care Manchester New Hampshire
United States Cancer Center of Kansas-Manhattan Manhattan Kansas
United States Holy Family Memorial Hospital Manitowoc Wisconsin
United States Cleveland Clinic Cancer Center Mansfield Mansfield Ohio
United States OhioHealth Mansfield Hospital Mansfield Ohio
United States Fairview Clinics and Surgery Center Maple Grove Maple Grove Minnesota
United States Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota
United States Saint John's Hospital - Healtheast Maplewood Minnesota
United States Marietta Memorial Hospital Marietta Ohio
United States Bay Area Medical Center Marinette Wisconsin
United States Saint Vincent Hospital Cancer Center at Marinette Marinette Wisconsin
United States OhioHealth Marion General Hospital Marion Ohio
United States Saint Mary's Oncology/Hematology Associates of Marlette Marlette Michigan
United States Marshfield Medical Center-Marshfield Marshfield Wisconsin
United States Contra Costa Regional Medical Center Martinez California
United States Sovah Health Martinsville Martinsville Virginia
United States Mercy Medical Center - North Iowa Mason City Iowa
United States Matthews Radiation Oncology Center Matthews North Carolina
United States Novant Health Cancer Institute - Matthews Matthews North Carolina
United States Carle Physician Group-Mattoon/Charleston Mattoon Illinois
United States Toledo Clinic Cancer Centers-Maumee Maumee Ohio
United States Toledo Radiation Oncology at Northwest Ohio Onocolgy Center Maumee Ohio
United States Hillcrest Hospital Cancer Center Mayfield Heights Ohio
United States Loyola University Medical Center Maywood Illinois
United States Kaiser Permanente Tysons Corner Medical Center McLean Virginia
United States Cancer Center of Kansas - McPherson McPherson Kansas
United States Aspirus Medford Hospital Medford Wisconsin
United States Riddle Memorial Hospital Media Pennsylvania
United States Baptist Memorial Hospital and Cancer Center-Memphis Memphis Tennessee
United States The West Clinic - Mid-Town Memphis Tennessee
United States University of Tennessee Health Science Center Memphis Tennessee
United States UH Seidman Cancer Center at Lake Health Mentor Campus Mentor Ohio
United States Idaho Urologic Institute-Meridian Meridian Idaho
United States Saint Luke's Cancer Institute - Meridian Meridian Idaho
United States Premier Oncology Hematology Associates Merrillville Indiana
United States East Jefferson General Hospital Metairie Louisiana
United States University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida
United States Franciscan Saint Anthony Health-Michigan City Michigan City Indiana
United States Woodland Cancer Care Center Michigan City Indiana
United States UH Seidman Cancer Center at Southwest General Hospital Middleburg Heights Ohio
United States Dayton Physicians LLC-Signal Point Middletown Ohio
United States Middlesex Hospital Middletown Connecticut
United States Abbott-Northwestern Hospital Minneapolis Minnesota
United States Health Partners Inc Minneapolis Minnesota
United States Hennepin County Medical Center Minneapolis Minnesota
United States Marshfield Clinic-Minocqua Center Minocqua Wisconsin
United States Trinity Cancer Care Center Minot North Dakota
United States Memorial Regional Cancer Center Day Road Mishawaka Indiana
United States Michiana Hematology Oncology PC-Mishawaka Mishawaka Indiana
United States Saint Joseph Regional Medical Center-Mishawaka Mishawaka Indiana
United States Community Medical Hospital Missoula Montana
United States Montana Cancer Specialists Missoula Montana
United States Saint Patrick Hospital - Community Hospital Missoula Montana
United States Kaiser Permanente-Modesto Modesto California
United States Memorial Medical Center Modesto California
United States Holy Family Medical Center Monmouth Illinois
United States Illinois CancerCare-Monmouth Monmouth Illinois
United States Mercy Memorial Hospital Monroe Michigan
United States Ochsner LSU Health Monroe Medical Center Monroe Louisiana
United States Toledo Clinic Cancer Centers-Monroe Monroe Michigan
United States Novant Health Cancer Institute - Mooresville Mooresville North Carolina
United States Saint Claire Regional Medical Center Morehead Kentucky
United States Morristown Medical Center Morristown New Jersey
United States McLaren Cancer Institute-Macomb Mount Clemens Michigan
United States Virtua Memorial Mount Holly New Jersey
United States Northern Westchester Hospital Mount Kisco New York
United States Lowcountry Hematology Oncology PA-Mount Pleasant Mount Pleasant South Carolina
United States McLaren Cancer Institute-Central Michigan Mount Pleasant Michigan
United States Good Samaritan Regional Health Center Mount Vernon Illinois
United States Knox Community Hospital Mount Vernon Ohio
United States Skagit Valley Hospital Mount Vernon Washington
United States El Camino Hospital Mountain View California
United States Palo Alto Medical Foundation-Camino Division Mountain View California
United States Palo Alto Medical Foundation-Gynecologic Oncology Mountain View California
United States Inspira Medical Center Mullica Hill Mullica Hill New Jersey
United States Mercy Health Mercy Campus Muskegon Michigan
United States Saint Alphonsus Medical Center-Nampa Nampa Idaho
United States Saint Luke's Cancer Institute - Nampa Nampa Idaho
United States Meharry Medical College Nashville Tennessee
United States Vanderbilt University/Ingram Cancer Center Nashville Tennessee
United States Baptist Memorial Hospital and Cancer Center-Union County New Albany Mississippi
United States Smilow Cancer Center/Yale-New Haven Hospital New Haven Connecticut
United States Yale University New Haven Connecticut
United States Louisiana State University Health Science Center New Orleans Louisiana
United States Ochsner Medical Center Jefferson New Orleans Louisiana
United States University Medical Center New Orleans New Orleans Louisiana
United States Cancer Center of Western Wisconsin New Richmond Wisconsin
United States New Ulm Medical Center New Ulm Minnesota
United States Laura and Isaac Perlmutter Cancer Center at NYU Langone New York New York
United States NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York New York
United States Christiana Care Health System-Christiana Hospital Newark Delaware
United States Christiana Gynecologic Oncology LLC Newark Delaware
United States Delaware Clinical and Laboratory Physicians PA Newark Delaware
United States Helen F Graham Cancer Center Newark Delaware
United States Licking Memorial Hospital Newark Ohio
United States Medical Oncology Hematology Consultants PA Newark Delaware
United States Newark Radiation Oncology Newark Ohio
United States Providence Newberg Medical Center Newberg Oregon
United States Cancer Center of Kansas - Newton Newton Kansas
United States Lakeland Hospital Niles Niles Michigan
United States Faith Regional Health Services Carson Cancer Center Norfolk Nebraska
United States Carle Cancer Institute Normal Normal Illinois
United States Yale-New Haven Hospital North Haven Medical Center North Haven Connecticut
United States Great Plains Health Callahan Cancer Center North Platte Nebraska
United States Sutter Cancer Research Consortium Novato California
United States Cancer Care Center of O'Fallon O'Fallon Illinois
United States Advocate Christ Medical Center Oak Lawn Illinois
United States Alta Bates Summit Medical Center - Summit Campus Oakland California
United States Bay Area Tumor Institute Oakland California
United States Hematology and Oncology Associates-Oakland Oakland California
United States Highland General Hospital Oakland California
United States Kaiser Permanente-Oakland Oakland California
United States Tom K Lee Inc Oakland California
United States Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls Wisconsin
United States Mercy Hospital Oklahoma City Oklahoma City Oklahoma
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Olathe Health Cancer Center Olathe Kansas
United States MedStar Montgomery Medical Center Olney Maryland
United States Capital Medical Center Olympia Washington
United States Providence - Saint Peter Hospital Olympia Washington
United States Alegent Health Bergan Mercy Medical Center Omaha Nebraska
United States Alegent Health Immanuel Medical Center Omaha Nebraska
United States Alegent Health Lakeside Hospital Omaha Nebraska
United States Creighton University Medical Center Omaha Nebraska
United States Hematology and Oncology Consultants PC Omaha Nebraska
United States Missouri Valley Cancer Consortium Omaha Nebraska
United States Nebraska Cancer Specialists - Omaha Omaha Nebraska
United States Oncology Hematology West PC Omaha Nebraska
United States Urology Cancer Center PC Omaha Nebraska
United States Kaiser Permanente-Ontario Ontario California
United States Saint Alphonsus Medical Center-Ontario Ontario Oregon
United States Memorial GYN Plus Ooltewah Tennessee
United States Saint Joseph Hospital - Orange Orange California
United States Smilow Cancer Hospital-Orange Care Center Orange Connecticut
United States UC Irvine Health/Chao Family Comprehensive Cancer Center Orange California
United States Saint Charles Hospital Oregon Ohio
United States Toledo Clinic Cancer Centers-Oregon Oregon Ohio
United States Providence Willamette Falls Medical Center Oregon City Oregon
United States Illinois CancerCare-Ottawa Clinic Ottawa Illinois
United States Ottawa Regional Hospital and Healthcare Center Ottawa Illinois
United States Radiation Oncology of Northern Illinois Ottawa Illinois
United States Menorah Medical Center Overland Park Kansas
United States Saint Luke's South Hospital Overland Park Kansas
United States University of Kansas Cancer Center-Overland Park Overland Park Kansas
United States Baptist Memorial Hospital and Cancer Center-Oxford Oxford Mississippi
United States Palo Alto Medical Foundation Health Care Palo Alto California
United States Kaiser Permanente - Panorama City Panorama City California
United States Paoli Memorial Hospital Paoli Pennsylvania
United States Midlands Community Hospital Papillion Nebraska
United States Parker Adventist Hospital Parker Colorado
United States Rocky Mountain Cancer Centers-Parker Parker Colorado
United States University Hospitals Parma Medical Center Parma Ohio
United States Cancer Center of Kansas - Parsons Parsons Kansas
United States Keck Medical Center of USC Pasadena Pasadena California
United States Singing River Hospital Pascagoula Mississippi
United States Illinois CancerCare-Pekin Pekin Illinois
United States OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center Pekin Illinois
United States Illinois CancerCare-Peoria Peoria Illinois
United States Methodist Medical Center of Illinois Peoria Illinois
United States OSF Saint Francis Medical Center Peoria Illinois
United States OSF Saint Francis Radiation Oncology at Peoria Cancer Center Peoria Illinois
United States Proctor Hospital Peoria Illinois
United States Mercy Health Perrysburg Cancer Center Perrysburg Ohio
United States Illinois CancerCare-Peru Peru Illinois
United States Illinois Valley Hospital Peru Illinois
United States Valley Radiation Oncology Peru Illinois
United States McLaren Cancer Institute-Northern Michigan Petoskey Michigan
United States Cancer Center at Saint Joseph's Phoenix Arizona
United States Phoenixville Hospital Phoenixville Pennsylvania
United States Ascension Via Christi - Pittsburg Pittsburg Kansas
United States South Florida Baptist Hospital Plant City Florida
United States East Bay Medical Oncology Hematology Medical Associates Inc-Pleasant Hill Pleasant Hill California
United States Valley Medical Oncology Consultants Pleasanton California
United States Michiana Hematology Oncology PC-Plymouth Plymouth Indiana
United States Chilton Medical Center Pompton New Jersey
United States 21st Century Oncology-Pontiac Pontiac Michigan
United States Hope Cancer Center Pontiac Michigan
United States Newland Medical Associates-Pontiac Pontiac Michigan
United States Saint Joseph Mercy Oakland Pontiac Michigan
United States Lake Huron Medical Center Port Huron Michigan
United States Jefferson Healthcare Port Townsend Washington
United States Kaiser Permanente Northwest Portland Oregon
United States Providence Portland Medical Center Portland Oregon
United States Providence Saint Vincent Medical Center Portland Oregon
United States Southern Ohio Medical Center Portsmouth Ohio
United States Kootenai Clinic Cancer Services - Post Falls Post Falls Idaho
United States Geisinger Cancer Services-Pottsville Pottsville Pennsylvania
United States Harrison HealthPartners Hematology and Oncology-Poulsbo Poulsbo Washington
United States Peninsula Cancer Center Poulsbo Washington
United States Cancer Center of Kansas - Pratt Pratt Kansas
United States Illinois CancerCare-Princeton Princeton Illinois
United States Princeton Community Hospital Princeton West Virginia
United States Rocky Mountain Cancer Centers - Pueblo Pueblo Colorado
United States Saint Mary Corwin Medical Center Pueblo Colorado
United States MultiCare Good Samaritan Hospital Puyallup Washington
United States Tacoma/Valley Radiation Oncology Centers-Puyallup Puyallup Washington
United States Eisenhower Medical Center Rancho Mirage California
United States Kaiser Permanente-Redwood City Redwood City California
United States Spectrum Health Reed City Hospital Reed City Michigan
United States Beebe Health Campus Rehoboth Beach Delaware
United States Valley Medical Center Renton Washington
United States Ascension Saint Mary's Hospital Rhinelander Wisconsin
United States Marshfield Medical Center-Rice Lake Rice Lake Wisconsin
United States Kaiser Permanente-Richmond Richmond California
United States Reid Health Richmond Indiana
United States Presbyterian Rust Medical Center/Jorgensen Cancer Center Rio Rancho New Mexico
United States West Suburban Medical Center River Forest Illinois
United States Kaiser Permanente-Riverside Riverside California
United States North Memorial Medical Health Center Robbinsdale Minnesota
United States Mayo Clinic in Rochester Rochester Minnesota
United States University of Rochester Rochester New York
United States Great Lakes Cancer Management Specialists-Rochester Hills Rochester Hills Michigan
United States OSF Saint Anthony Medical Center Rockford Illinois
United States Nash General Hospital Rocky Mount North Carolina
United States Highlands Oncology Group - Rogers Rogers Arkansas
United States Hematology Oncology Associates of Central New York-Rome Rome New York
United States Kaiser Permanente-Roseville Roseville California
United States Sutter Cancer Centers Radiation Oncology Services-Roseville Roseville California
United States Sutter Roseville Medical Center Roseville California
United States William Beaumont Hospital-Royal Oak Royal Oak Michigan
United States Kaiser Permanente - Sacramento Sacramento California
United States Kaiser Permanente Downtown Commons Sacramento California
United States Kaiser Permanente-South Sacramento Sacramento California
United States Sutter Medical Center Sacramento Sacramento California
United States Ascension Saint Mary's Hospital Saginaw Michigan
United States Oncology Hematology Associates of Saginaw Valley PC Saginaw Michigan
United States Coborn Cancer Center at Saint Cloud Hospital Saint Cloud Minnesota
United States Saint Cloud Hospital Saint Cloud Minnesota
United States Heartland Regional Medical Center Saint Joseph Missouri
United States Lakeland Medical Center Saint Joseph Saint Joseph Michigan
United States Marie Yeager Cancer Center Saint Joseph Michigan
United States Saint Joseph Oncology Inc Saint Joseph Missouri
United States Mercy Hospital South Saint Louis Missouri
United States Missouri Baptist Medical Center Saint Louis Missouri
United States Siteman Cancer Center at Christian Hospital Saint Louis Missouri
United States Veteran's Affairs Medical Center - Saint Louis Saint Louis Missouri
United States Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota
United States Regions Hospital Saint Paul Minnesota
United States United Hospital Saint Paul Minnesota
United States Saint Anthony's Hospital Cancer Care Center Saint Petersburg Florida
United States Sainte Genevieve County Memorial Hospital Sainte Genevieve Missouri
United States Cancer Center of Kansas - Salina Salina Kansas
United States Salina Regional Health Center Salina Kansas
United States Audie L Murphy VA Hospital San Antonio Texas
United States Cancer Therapy and Research Center at The UT Health Science Center at San Antonio San Antonio Texas
United States University Hospital San Antonio Texas
United States University of Texas Health Science Center at San Antonio San Antonio Texas
United States Kaiser Permanente-San Diego Mission San Diego California
United States Kaiser Permanente-San Diego Zion San Diego California
United States California Pacific Medical Center-Pacific Campus San Francisco California
United States Kaiser Permanente-San Francisco San Francisco California
United States Kaiser Permanente-Santa Teresa-San Jose San Jose California
United States Kaiser Permanente San Leandro San Leandro California
United States Pacific Central Coast Health Center-San Luis Obispo San Luis Obispo California
United States Kaiser Permanente-San Marcos San Marcos California
United States Doctors Medical Center- JC Robinson Regional Cancer Center San Pablo California
United States Kaiser Permanente-San Rafael San Rafael California
United States Kaiser San Rafael-Gallinas San Rafael California
United States Kootenai Cancer Clinic Sandpoint Idaho
United States Essentia Health Sandstone Sandstone Minnesota
United States North Coast Cancer Care Sandusky Ohio
United States UH Seidman Cancer Center at Firelands Regional Medical Center Sandusky Ohio
United States Kaiser Permanente Medical Center - Santa Clara Santa Clara California
United States Palo Alto Medical Foundation-Santa Cruz Santa Cruz California
United States Christus Saint Vincent Regional Cancer Center Santa Fe New Mexico
United States Mission Hope Medical Oncology - Santa Maria Santa Maria California
United States Kaiser Permanente-Santa Rosa Santa Rosa California
United States Sutter Pacific Medical Foundation Santa Rosa California
United States Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah Georgia
United States Regional West Medical Center Cancer Center Scottsbluff Nebraska
United States Community Medical Center Scranton Pennsylvania
United States TidalHealth Nanticoke / Allen Cancer Center Seaford Delaware
United States Fred Hutchinson Cancer Research Center Seattle Washington
United States Harborview Medical Center Seattle Washington
United States Kaiser Permanente Washington Seattle Washington
United States Minor and James Medical PLLC Seattle Washington
United States Pacific Gynecology Specialists Seattle Washington
United States Pacific Medical Center-First Hill Seattle Washington
United States Swedish Medical Center-Ballard Campus Seattle Washington
United States Swedish Medical Center-First Hill Seattle Washington
United States University of Washington Medical Center - Montlake Seattle Washington
United States Virginia Mason Medical Center Seattle Washington
United States PeaceHealth United General Medical Center Sedro-Woolley Washington
United States Geisinger Medical Oncology-Selinsgrove Selinsgrove Pennsylvania
United States Prisma Health Cancer Institute - Seneca Seneca South Carolina
United States Saint Francis Regional Medical Center Shakopee Minnesota
United States HSHS Saint Nicholas Hospital Sheboygan Wisconsin
United States Cleveland Hematology and Oncology Associates PC Shelby North Carolina
United States Providence Regional Cancer System-Shelton Shelton Washington
United States Jewish Hospital Medical Center South Shepherdsville Kentucky
United States Welch Cancer Center Sheridan Wyoming
United States Highland Clinic Shreveport Louisiana
United States LSU Health Sciences Center at Shreveport Shreveport Louisiana
United States Dayton Physicians LLC-Wilson Sidney Ohio
United States Mercy Medical Center-Sioux City Sioux City Iowa
United States Saint Luke's Regional Medical Center Sioux City Iowa
United States Siouxland Regional Cancer Center Sioux City Iowa
United States Avera Cancer Institute Sioux Falls South Dakota
United States Sanford Cancer Center Oncology Clinic Sioux Falls South Dakota
United States Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota
United States Phelps Memorial Hospital Center Sleepy Hollow New York
United States Memorial Hospital of South Bend South Bend Indiana
United States Michiana Hematology Oncology PC-South Bend South Bend Indiana
United States Kaiser Permanente-South San Francisco South San Francisco California
United States The West Clinic - Southaven Southaven Mississippi
United States Ascension Providence Hospitals - Southfield Southfield Michigan
United States Baptist Memorial Hospital and Cancer Center-Desoto Southhaven Mississippi
United States Spartanburg Medical Center Spartanburg South Carolina
United States Cancer Care Northwest - Spokane South Spokane Washington
United States Evergreen Hematology and Oncology PS Spokane Washington
United States MultiCare Deaconess Cancer and Blood Specialty Center - Downtown Spokane Washington
United States MultiCare Deaconess Cancer and Blood Specialty Center - North Spokane Washington
United States Rockwood Clinic Spokane Washington
United States MultiCare Deaconess Cancer and Blood Specialty Center - Valley Spokane Valley Washington
United States Central Illinois Hematology Oncology Center Springfield Illinois
United States CoxHealth South Hospital Springfield Missouri
United States Memorial Medical Center Springfield Illinois
United States Mercy Hospital Springfield Springfield Missouri
United States Mercy Medical Center Springfield Massachusetts
United States Southern Illinois University School of Medicine Springfield Illinois
United States Springfield Clinic Springfield Illinois
United States Springfield Regional Cancer Center Springfield Ohio
United States Springfield Regional Medical Center Springfield Ohio
United States Stamford Hospital/Bennett Cancer Center Stamford Connecticut
United States Geisinger Medical Group State College Pennsylvania
United States Bhadresh Nayak MD PC-Sterling Heights Sterling Heights Michigan
United States Ascension Saint Michael's Hospital Stevens Point Wisconsin
United States Marshfield Medical Center-River Region at Stevens Point Stevens Point Wisconsin
United States Lakeview Hospital Stillwater Minnesota
United States Kaiser Permanente-Stockton Stockton California
United States Stony Brook University Medical Center Stony Brook New York
United States Cleveland Clinic Cancer Center Strongsville Strongsville Ohio
United States Green Bay Oncology - Sturgeon Bay Sturgeon Bay Wisconsin
United States Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay Wisconsin
United States Missouri Baptist Sullivan Hospital Sullivan Missouri
United States Overlook Hospital Summit New Jersey
United States Palo Alto Medical Foundation-Sunnyvale Sunnyvale California
United States Missouri Baptist Outpatient Center-Sunset Hills Sunset Hills Missouri
United States Southwest Illinois Health Services LLP Swansea Illinois
United States ProMedica Flower Hospital Sylvania Ohio
United States Hematology Oncology Associates of Central New York-Onondaga Hill Syracuse New York
United States Franciscan Research Center-Northwest Medical Plaza Tacoma Washington
United States MultiCare Allenmore Hospital Tacoma Washington
United States MultiCare Tacoma General Hospital Tacoma Washington
United States Northwest Medical Specialties PLLC Tacoma Washington
United States Saint Joseph Medical Center Tacoma Washington
United States Tacoma/Valley Radiation Oncology Centers-Jackson Hall Tacoma Washington
United States Tacoma/Valley Radiation Oncology Centers-Saint Joe's Tacoma Washington
United States Moffitt Cancer Center Tampa Florida
United States Ascension Saint Joseph Hospital Tawas City Michigan
United States Scott and White Memorial Hospital Temple Texas
United States Rocky Mountain Cancer Centers-Thornton Thornton Colorado
United States Mercy Hospital of Tiffin Tiffin Ohio
United States Mercy Health - Saint Anne Hospital Toledo Ohio
United States ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo Ohio
United States Saint Vincent Mercy Medical Center Toledo Ohio
United States Toledo Clinic Cancer Centers-Toledo Toledo Ohio
United States Toledo Community Hospital Oncology Program CCOP Toledo Ohio
United States University of Toledo Toledo Ohio
United States Community Medical Center Toms River New Jersey
United States Cotton O'Neil Cancer Center / Stormont Vail Health Topeka Kansas
United States University of Kansas Health System Saint Francis Campus Topeka Kansas
United States Smilow Cancer Hospital-Torrington Care Center Torrington Connecticut
United States Munson Medical Center Traverse City Michigan
United States Dayton Physicians LLC-Upper Valley Troy Ohio
United States Upper Valley Medical Center Troy Ohio
United States William Beaumont Hospital - Troy Troy Michigan
United States Smilow Cancer Hospital Care Center-Trumbull Trumbull Connecticut
United States Banner University Medical Center - Tucson Tucson Arizona
United States University of Arizona Cancer Center-North Campus Tucson Arizona
United States University of Arizona Cancer Center-Orange Grove Campus Tucson Arizona
United States Saint Luke's Cancer Institute - Twin Falls Twin Falls Idaho
United States MGC Hematology Oncology-Union Union South Carolina
United States Carle Cancer Center Urbana Illinois
United States The Carle Foundation Hospital Urbana Illinois
United States Kaiser Permanente Medical Center-Vacaville Vacaville California
United States Sutter Cancer Centers Radiation Oncology Services-Vacaville Vacaville California
United States Kaiser Permanente-Vallejo Vallejo California
United States Sutter Solano Medical Center/Cancer Center Vallejo California
United States Porter Memorial Hospital Valparaiso Indiana
United States PeaceHealth Southwest Medical Center Vancouver Washington
United States Inspira Medical Center Vineland Vineland New Jersey
United States Essentia Health Virginia Clinic Virginia Minnesota
United States Virtua Voorhees Voorhees New Jersey
United States Ridgeview Medical Center Waconia Minnesota
United States University Hospitals Sharon Health Center Wadsworth Ohio
United States Maui Memorial Medical Center Wailuku Hawaii
United States Pacific Cancer Institute of Maui Wailuku Hawaii
United States Providence Saint Mary Regional Cancer Center Walla Walla Washington
United States Epic Care Cyberknife Center Walnut Creek California
United States Kaiser Permanente-Walnut Creek Walnut Creek California
United States Advanced Breast Care Center PLLC Warren Michigan
United States Great Lakes Cancer Management Specialists-Macomb Professional Building Warren Michigan
United States Macomb Hematology Oncology PC Warren Michigan
United States Michigan Breast Specialists-Warren Warren Michigan
United States Saint John Macomb-Oakland Hospital Warren Michigan
United States South Pointe Hospital Warrensville Heights Ohio
United States Northwestern Medicine Cancer Center Warrenville Warrenville Illinois
United States Kaiser Permanente-Capitol Hill Medical Center Washington District of Columbia
United States MedStar Georgetown University Hospital Washington District of Columbia
United States MedStar Washington Hospital Center Washington District of Columbia
United States Smilow Cancer Hospital-Waterbury Care Center Waterbury Connecticut
United States Smilow Cancer Hospital Care Center - Waterford Waterford Connecticut
United States MercyOne Waterloo Cancer Center Waterloo Iowa
United States Aspirus Regional Cancer Center Wausau Wisconsin
United States Marshfield Clinic-Wausau Center Wausau Wisconsin
United States Fulton County Health Center Wauseon Ohio
United States Cancer Center of Kansas - Wellington Wellington Kansas
United States Wenatchee Valley Hospital and Clinics Wenatchee Washington
United States Saint Mary's Oncology/Hematology Associates of West Branch West Branch Michigan
United States Chester County Hospital West Chester Pennsylvania
United States Mercy Medical Center-West Lakes West Des Moines Iowa
United States Methodist West Hospital West Des Moines Iowa
United States Veterans Affairs Connecticut Healthcare System-West Haven Campus West Haven Connecticut
United States Reading Hospital West Reading Pennsylvania
United States Saint Ann's Hospital Westerville Ohio
United States UH Seidman Cancer Center at Saint John Medical Center Westlake Ohio
United States UHHS-Westlake Medical Center Westlake Ohio
United States Marshfield Medical Center - Weston Weston Wisconsin
United States Michiana Hematology Oncology PC-Westville Westville Indiana
United States SCL Health Lutheran Medical Center Wheat Ridge Colorado
United States Dickstein Cancer Treatment Center White Plains New York
United States White River Junction Veteran Administration Medical Center White River Junction Vermont
United States Presbyterian Intercommunity Hospital Whittier California
United States Ascension Via Christi Hospitals Wichita Wichita Kansas
United States Associates In Womens Health Wichita Kansas
United States Cancer Center of Kansas - Wichita Wichita Kansas
United States Cancer Center of Kansas-Wichita Medical Arts Tower Wichita Kansas
United States Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre Pennsylvania
United States Rice Memorial Hospital Willmar Minnesota
United States Asplundh Cancer Pavilion Willow Grove Pennsylvania
United States Christiana Care Health System-Wilmington Hospital Wilmington Delaware
United States Cancer Center of Kansas - Winfield Winfield Kansas
United States Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids Wisconsin
United States Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids Wisconsin
United States Minnesota Oncology Hematology PA-Woodbury Woodbury Minnesota
United States Kaiser Permanente-Woodland Hills Woodland Hills California
United States Cleveland Clinic Wooster Family Health and Surgery Center Wooster Ohio
United States Wright-Patterson Medical Center Wright-Patterson Air Force Base Ohio
United States Lankenau Medical Center Wynnewood Pennsylvania
United States Fairview Lakes Medical Center Wyoming Minnesota
United States Metro Health Hospital Wyoming Michigan
United States Greene Memorial Hospital Xenia Ohio
United States North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima Washington
United States Providence Regional Cancer System-Yelm Yelm Washington
United States Rush-Copley Healthcare Center Yorkville Illinois
United States Huron Gastroenterology PC Ypsilanti Michigan
United States Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti Michigan
United States Genesis Healthcare System Cancer Care Center Zanesville Ohio

Sponsors (3)

Lead Sponsor Collaborator
SWOG Cancer Research Network Cancer Prevention Pharmaceuticals, Inc., National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Event rate, defined as rate of high-risk adenoma or second primary colorectal cancer (CRC) High risk adenoma is defined as either advanced adenoma (villous or tubulovillous histology, size >= 1 cm, or high grade dysplasia) or multiple adenomas (3 or more each > 0.3 cm). The primary analysis of the 3-year event rate will be performed using logistic regression, testing the main effect of treatment and adjusting for the baseline stratification factor. A two-arm binomial design without continuity correction will be used. 3 years after registration
Secondary Total advanced colorectal event rate, defined as the number of patients with at least one high risk adenoma, second primary CRC, CRC recurrence, or metastasis The analysis will be performed using logistic regression, testing the main effect of treatment and adjusting for the baseline stratification factor. A time-to-event analysis will be conducted if there is no evidence of differential rates of on-study colonoscopies. To evaluate whether intervention effects are enduring, an analysis of post-treatment follow-up, examining colorectal event rates through year 8 will be performed. Up to 8 years
Secondary Colon cancer recurrence Statistical assessments of association between the biomarker and the recurrence endpoints will be performed after converting the biomarker scores to ranks, which will facilitate detection of monotonic relationship(s). Up to 8 years
Secondary High-grade dysplasia The analysis will be performed using logistic regression, testing the main effect of treatment and adjusting for the baseline stratification factor. A time-to-event analysis will be conducted if there is no evidence of differential rates of on-study colonoscopies. To evaluate whether intervention effects are enduring, an analysis of post-treatment follow-up, examining colorectal event rates through year 8 will be performed. Up to 8 years
Secondary Adenomas with villous features, defined as villous histology (villous and tubulovillous adenomas) The analysis will be performed using logistic regression, testing the main effect of treatment and adjusting for the baseline stratification factor. A time-to-event analysis will be conducted if there is no evidence of differential rates of on-study colonoscopies. To evaluate whether intervention effects are enduring, an analysis of post-treatment follow-up, examining colorectal event rates through year 8 will be performed. Up to 8 years
Secondary Adenomas >= 1 cm The analysis will be performed using logistic regression, testing the main effect of treatment and adjusting for the baseline stratification factor. A time-to-event analysis will be conducted if there is no evidence of differential rates of on-study colonoscopies. To evaluate whether intervention effects are enduring, an analysis of post-treatment follow-up, examining colorectal event rates through year 8 will be performed. Up to 8 years
Secondary Multiple adenomas, defined as 3 or more adenomas all measuring > 0.3 cm The analysis will be performed using logistic regression, testing the main effect of treatment and adjusting for the baseline stratification factor. A time-to-event analysis will be conducted if there is no evidence of differential rates of on-study colonoscopies. To evaluate whether intervention effects are enduring, an analysis of post-treatment follow-up, examining colorectal event rates through year 8 will be performed. Up to 8 years
Secondary The number of patients with development of any adenoma > 0.3 cm The analysis will be performed using logistic regression, testing the main effect of treatment and adjusting for the baseline stratification factor. A time-to-event analysis will be conducted if there is no evidence of differential rates of on-study colonoscopies. To evaluate whether intervention effects are enduring, an analysis of post-treatment follow-up, examining colorectal event rates through year 8 will be performed. Up to 8 years
Secondary Total colorectal event rate, defined as the number of patients with at least one colorectal event (advanced colorectal event or adenoma > 0.3 cm) The analysis will be performed using logistic regression, testing the main effect of treatment and adjusting for the baseline stratification factor. A time-to-event analysis will be conducted if there is no evidence of differential rates of on-study colonoscopies. To evaluate whether intervention effects are enduring, an analysis of post-treatment follow-up, examining colorectal event rates through year 8 will be performed. Up to 8 years
Secondary Time to first clinically apparent high-risk adenoma or second primary CRC The analysis will be performed using logistic regression, testing the main effect of treatment and adjusting for the baseline stratification factor. A time-to-event analysis will be conducted if there is no evidence of differential rates of on-study colonoscopies. To evaluate whether intervention effects are enduring, an analysis of post-treatment follow-up, examining colorectal event rates through year 8 will be performed. From date of registration to date at which high-risk adenoma or second primary CRC is detected, up to 8 years
Secondary Toxicity Qualitative and quantitative assessment of toxicity, collected as CTCAE adverse events. Particular adverse events of interest include thrombotic cardiovascular and ototoxic events at or above a specified grade (e.g., Grade III or worse). All patients who receive any treatment will be included in the analysis of adverse events. Up to 3 years
Secondary Baseline statin use The analysis of the interaction of statin use and the 3-year event rate will be performed using logistic regression. Up to 3 years
Secondary Baseline meat consumption The analysis of the interaction of meat consumption and the 3-year event rate will be performed using logistic regression. Up to 3 years
Secondary PK analysis SNPs with minor allele frequencies greater than 0.20 will be selected for SNP genotyping. The smallest set of SNPs that tag the common variation (frequency > 0.20) in all of the representative ethnic groups will be used. The genotype data, treatment characteristics and endpoints of interest will be analyzed using the pharmacogenetic-environment interaction approach described by Wacholder and colleagues. Up to 3 years
Secondary Biomarker identification based on Integrated Comprehensive Droplet Digital Detection technology The nature of the relationship between biomarker values identified by Integrated Comprehensive Droplet Digital Detection technology and the aggregate primary endpoint (high-risk adenoma or second primary CRC) will be assessed. Statistical assessments of association between the biomarker and the recurrence endpoints will be performed after converting the biomarker scores to ranks, which will facilitate detection of monotonic relationship(s). Up to 3 years (though the timing of this isn't clear to me)
Secondary Cancer type (colorectal vs rectal) The analysis of the interaction of cancer type (colorectal vs rectal) and the 3-year event rate will be performed using logistic regression. Up to 3 years
See also
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