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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00996047
Other study ID # S9007
Secondary ID SWOG-9007U10CA03
Status Completed
Phase N/A
First received October 15, 2009
Last updated March 5, 2015
Start date July 1991
Est. completion date January 2012

Study information

Verified date March 2015
Source Southwest Oncology Group
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

RATIONALE: Studying samples of bone marrow and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research study is looking at bone marrow and blood samples from patients with leukemia or other hematopoietic cancers.


Description:

Primary objective:

* Maintain and expand a database of cytogenetic information on leukemia patients.

Other objectives as funding permits:

- Determine the frequency and prognostic significance of cytogenetic abnormalities in bone marrow or peripheral blood cells in patients with leukemia prior to treatment and at various times during treatment undergoing treatment on a companion clinical trial.

- Correlate the presence of cytogenetic features with clinical, pathophysiological, cellular, and molecular characteristics in these patients.

- Provide quality control for all Southwest Oncology Group cytogenetic data.

OUTLINE: Bone marrow and/or peripheral blood samples from patients on specific treatment protocols for leukemia are analyzed for cytogenetic abnormalities. Samples from patients with chronic lymphocytic leukemia (CLL) are analyzed for trisomy 12 by fluorescence in situ hybridization and conventional cytogenetics.

PROJECTED ACCRUAL: Approximately 2,500 patients (1,200 with first-line acute myeloid leukemia [AML], 500 with first-line acute lymphoblastic leukemia [ALL], 200 with relapsed AML, 125 with chronic phase chronic myelogenous leukemia [CML], 100 with accelerated phase or blastic phase CML, 250 with hairy cell leukemia, and 125 with relapsed ALL or CLL) will be accrued for this study within 5 years.


Recruitment information / eligibility

Status Completed
Enrollment 3341
Est. completion date January 2012
Est. primary completion date January 2012
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility DISEASE CHARACTERISTICS:

- Registered on one of the following Southwest Oncology Group treatment protocols:

- SWOG-8326, SWOG-8600, SWOG-8612, SWOG-9034, SWOG-9108, OR any new leukemia protocol approved as of 1990

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

Study Design

N/A


Related Conditions & MeSH terms


Intervention

Genetic:
cytogenetic analysis

fluorescence in situ hybridization


Locations

Country Name City State
United States Kapiolani Medical Center at Pali Momi Aiea Hawaii
United States McDowell Cancer Center at Akron General Medical Center Akron Ohio
United States University of New Mexico Cancer Center Albuquerque New Mexico
United States Tulane Cancer Center Office of Clinical Research Alexandria Louisiana
United States Saint Anthony's Hospital at Saint Anthony's Health Center Alton Illinois
United States Harrington Cancer Center Amarillo Texas
United States McFarland Clinic, PC Ames Iowa
United States Island Hospital Cancer Care Center at Island Hospital Anacortes Washington
United States Providence Cancer Center Anchorage Alaska
United States AnMed Cancer Center Anderson South Carolina
United States CCOP - Michigan Cancer Research Consortium Ann Arbor Michigan
United States Saint Joseph Mercy Cancer Center Ann Arbor Michigan
United States University of Michigan Comprehensive Cancer Center Ann Arbor Michigan
United States CCOP - Atlanta Regional Atlanta Georgia
United States Northside Hospital Cancer Center Atlanta Georgia
United States Piedmont Hospital Atlanta Georgia
United States Saint Joseph's Hospital of Atlanta Atlanta Georgia
United States Rush-Copley Cancer Care Center Aurora Illinois
United States WellStar Cobb Hospital Austell Georgia
United States Alvin and Lois Lapidus Cancer Institute at Sinai Hospital Baltimore Maryland
United States CancerCare of Maine at Eastern Maine Medical Center Bangor Maine
United States Battle Creek Health System Cancer Care Center Battle Creek Michigan
United States St. Francis Hospital and Health Centers - Beech Grove Campus Beech Grove Indiana
United States Mary Rutan Hospital Bellefontaine Ohio
United States St. Joseph Cancer Center Bellingham Washington
United States Alta Bates Summit Comprehensive Cancer Center Berkeley California
United States Hematology Oncology Associates of the Quad Cities Bettendorf Iowa
United States Mecosta County Medical Center Big Rapids Michigan
United States Billings Clinic - Downtown Billings Montana
United States CCOP - Montana Cancer Consortium Billings Montana
United States Hematology-Oncology Centers of the Northern Rockies - Billings Billings Montana
United States St. Vincent Healthcare Cancer Care Services Billings Montana
United States Mountain States Tumor Institute at St. Luke's Regional Medical Center Boise Idaho
United States Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center Boise Idaho
United States Bozeman Deaconess Cancer Center Bozeman Montana
United States Olympic Hematology and Oncology Bremerton Washington
United States Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center Burbank California
United States Highline Medical Center Cancer Center Burien Washington
United States Peninsula Medical Center Burlingame California
United States St. James Healthcare Cancer Care Butte Montana
United States Aultman Cancer Center at Aultman Hospital Canton Ohio
United States Mercy Cancer Center at Mercy Medical Center Canton Ohio
United States Saint Francis Medical Center Cape Girardeau Missouri
United States Providence Centralia Hospital Centralia Washington
United States Cancer Center of Kansas, PA - Chanute Chanute Kansas
United States Hollings Cancer Center at Medical University of South Carolina Charleston South Carolina
United States Blumenthal Cancer Center at Carolinas Medical Center Charlotte North Carolina
United States Presbyterian Cancer Center at Presbyterian Hospital Charlotte North Carolina
United States University of Chicago Cancer Research Center Chicago Illinois
United States Adena Regional Medical Center Chillicothe Ohio
United States Charles M. Barrett Cancer Center at University Hospital Cincinnati Ohio
United States Clackamas Radiation Oncology Center Clackamas Oregon
United States Cleveland Clinic Taussig Cancer Center Cleveland Ohio
United States Medical Oncology and Hematology Associates - West Des Moines Clive Iowa
United States CCOP - Columbus Columbus Ohio
United States Doctors Hospital at Ohio Health Columbus Ohio
United States Grant Medical Center Cancer Care Columbus Ohio
United States John B. Amos Cancer Center Columbus Georgia
United States Mount Carmel Health - West Hospital Columbus Ohio
United States Riverside Methodist Hospital Cancer Care Columbus Ohio
United States Baylor University Medical Center - Dallas Dallas Texas
United States Danville Regional Medical Center Danville Virginia
United States Genesis Regional Cancer Center at Genesis Medical Center Davenport Iowa
United States CCOP - Dayton Dayton Ohio
United States David L. Rike Cancer Center at Miami Valley Hospital Dayton Ohio
United States Good Samaritan Hospital Dayton Ohio
United States Grandview Hospital Dayton Ohio
United States Samaritan North Cancer Care Center Dayton Ohio
United States Oakwood Cancer Center at Oakwood Hospital and Medical Center Dearborn Michigan
United States Charles B. Eberhart Cancer Center at DeKalb Medical Center Decatur Georgia
United States Decatur Memorial Hospital Cancer Care Institute Decatur Illinois
United States Grady Memorial Hospital Delaware Ohio
United States CCOP - Iowa Oncology Research Association Des Moines Iowa
United States John Stoddard Cancer Center at Iowa Lutheran Hospital Des Moines Iowa
United States John Stoddard Cancer Center at Iowa Methodist Medical Center Des Moines Iowa
United States Medical Oncology and Hematology Associates at John Stoddard Cancer Center Des Moines Iowa
United States Medical Oncology and Hematology Associates at Mercy Cancer Center Des Moines Iowa
United States Mercy Cancer Center at Mercy Medical Center - Des Moines Des Moines Iowa
United States Barbara Ann Karmanos Cancer Institute Detroit Michigan
United States Josephine Ford Cancer Center at Henry Ford Hospital Detroit Michigan
United States Cancer Center of Kansas, PA - Dodge City Dodge City Kansas
United States CCOP - Duluth Duluth Minnesota
United States Duluth Clinic Cancer Center - Duluth Duluth Minnesota
United States Miller - Dwan Medical Center Duluth Minnesota
United States Cancer Center of Kansas, PA - El Dorado El Dorado Kansas
United States Piedmont Fayette Hospital Fayetteville Georgia
United States St. Francis Hospital Federal Way Washington
United States Blanchard Valley Medical Associates Findlay Ohio
United States Genesys Hurley Cancer Institute Flint Michigan
United States Hurley Medical Center Flint Michigan
United States McLeod Regional Medical Center Florence South Carolina
United States Front Range Cancer Specialists Fort Collins Colorado
United States Poudre Valley Hospital Fort Collins Colorado
United States Cancer Center of Kansas - Fort Scott Fort Scott Kansas
United States Middletown Regional Hospital Franklin Ohio
United States Hembree Mercy Cancer Center at St. Edward Mercy Medical Center Ft. Smith Arkansas
United States Wayne Memorial Hospital, Incorporated Goldsboro North Carolina
United States Genesys Regional Medical Center Grand Blanc Michigan
United States Butterworth Hospital at Spectrum Health Grand Rapids Michigan
United States CCOP - Grand Rapids Grand Rapids Michigan
United States Lacks Cancer Center at Saint Mary's Health Care Grand Rapids Michigan
United States Big Sky Oncology Great Falls Montana
United States Great Falls Clinic - Main Facility Great Falls Montana
United States Sletten Cancer Institute at Benefis Healthcare Great Falls Montana
United States Green Bay Oncology, Limited at St. Mary's Hospital Green Bay Wisconsin
United States Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center Green Bay Wisconsin
United States St. Mary's Hospital Medical Center - Green Bay Green Bay Wisconsin
United States St. Vincent Hospital Regional Cancer Center Green Bay Wisconsin
United States Wayne Hospital Greenville Ohio
United States Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods Michigan
United States Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center Hartford Connecticut
United States Northern Montana Hospital Havre Montana
United States St. Peter's Hospital Helena Montana
United States Pardee Memorial Hospital Hendersonville North Carolina
United States Cancer Research Center of Hawaii Honolulu Hawaii
United States Hawaii Medical Center - East Honolulu Hawaii
United States Kapiolani Medical Center for Women and Children Honolulu Hawaii
United States OnCare Hawaii, Incorporated - Kuakini Honolulu Hawaii
United States OnCare Hawaii, Incorporated - Lusitana Honolulu Hawaii
United States Queen's Cancer Institute at Queen's Medical Center Honolulu Hawaii
United States Straub Clinic and Hospital, Incorporated Honolulu Hawaii
United States Tripler Army Medical Center Honolulu Hawaii
United States Baylor University Medical Center - Houston Houston Texas
United States Ben Taub General Hospital Houston Texas
United States St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital Houston Texas
United States Veterans Affairs Medical Center - Houston Houston Texas
United States Cancer Center of Kansas-Independence Independence Kansas
United States Foote Memorial Hospital Jackson Michigan
United States University of Mississippi Cancer Clinic Jackson Mississippi
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 Glacier Oncology, PLLC Kalispell Montana
United States Kalispell Medical Oncology at KRMC Kalispell Montana
United States Kalispell Regional Medical Center Kalispell Montana
United States Heartland Hematology Oncology Associates, Incorporated Kansas City Missouri
United States Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center Kansas City Kansas
United States North Kansas City Hospital Kansas City Missouri
United States Parvin Radiation Oncology Kansas City Missouri
United States Research Medical Center Kansas City Missouri
United States Saint Luke's Cancer Institute at Saint Luke's Hospital Kansas City Missouri
United States St. Joseph Medical Center Kansas City Missouri
United States Truman Medical Center - Hospital Hill Kansas City Missouri
United States Columbia Basin Hematology Kennewick Washington
United States Keesler Air Force Base Medical Center Kessler AFB Mississippi
United States Charles F. Kettering Memorial Hospital Kettering Ohio
United States Cancer Center of Kansas, PA - Kingman Kingman Kansas
United States Kinston Medical Specialists Kinston North Carolina
United States Thompson Cancer Survival Center Knoxville Tennessee
United States U.T. Medical Center Cancer Institute Knoxville Tennessee
United States Fairfield Medical Center Lancaster Ohio
United States Lancaster General Hospital Lancaster Pennsylvania
United States Sparrow Regional Cancer Center Lansing Michigan
United States CCOP - Nevada Cancer Research Foundation Las Vegas Nevada
United States Sunrise Hospital and Medical Center Las Vegas Nevada
United States Lawrence Memorial Hospital Lawrence Kansas
United States Gwinnett Medical Center Lawrenceville Georgia
United States Saint Luke's East - Lee's Summit Lee's Summit Missouri
United States Lucille P. Markey Cancer Center at University of Kentucky Lexington Kentucky
United States Cancer Center of Kansas, PA - Liberal Liberal Kansas
United States Liberty Hospital Liberty Missouri
United States Kauai Medical Clinic Lihue Hawaii
United States St. Mary Mercy Hospital Livonia Michigan
United States MedCentral - Mansfield Hospital Mansfield Ohio
United States Kennestone Cancer Center at Wellstar Kennestone Hospital Marietta Georgia
United States Strecker Cancer Center at Marietta Memorial Hospital Marietta Ohio
United States Bay Area Cancer Care Center at Bay Area Medical Center Marinette Wisconsin
United States Marshfield Clinic - Marshfield Center Marshfield Wisconsin
United States Tibotec Therapeutics - Division of Ortho Biotech Products, LP Marysville California
United States Cardinal Bernardin Cancer Center at Loyola University Medical Center Maywood Illinois
United States Cancer Center of Kansas, PA - McPherson McPherson Kansas
United States Saint Anthony Memorial Health Centers Michigan City Indiana
United States Providence Milwaukie Hospital Milwaukie Oregon
United States Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula Montana
United States Providence Cancer Center at Providence Hospital Mobile Alabama
United States Louisiana State University Health Sciences Center - Monroe Monroe Louisiana
United States Good Samaritan Regional Health Center Mount Vernon Illinois
United States Knox Community Hospital Mount Vernon Ohio
United States Skagit Valley Hospital Cancer Care Center Mount Vernon Washington
United States Mercy General Health Partners Muskegon Michigan
United States Licking Memorial Cancer Care Program at Licking Memorial Hospital Newark Ohio
United States Providence Newberg Medical Center Newberg Oregon
United States Cancer Center of Kansas, PA - Newton Newton Kansas
United States Mid-Illinois Hematology-Oncology Associates at Community Cancer Center Normal Illinois
United States Sutter Health - Western Division Cancer Research Group Novato California
United States Providence St. Peter Hospital Regional Cancer Center Olympia Washington
United States Methodist Estabrook Cancer Center Omaha Nebraska
United States Willamette Falls Hospital Oregon City Oregon
United States M.D. Anderson Cancer Center at Orlando Orlando Florida
United States Menorah Medical Center Overland Park Kansas
United States Saint Luke's Hospital - South Overland Park Kansas
United States Cancer Center of Kansas, PA - Parsons Parsons Kansas
United States Regional Cancer Center at Singing River Hospital Pascagoula Mississippi
United States St. Joseph Mercy Oakland Pontiac Michigan
United States Mercy Regional Cancer Center at Mercy Hospital Port Huron Michigan
United States Adventist Medical Center Portland Oregon
United States CCOP - Columbia River Oncology Program Portland Oregon
United States Knight Cancer Institute at Oregon Health and Science University Portland Oregon
United States Providence Cancer Center at Providence Portland Medical Center Portland Oregon
United States Providence St. Vincent Medical Center Portland Oregon
United States Harrison Poulsbo Hematology and Onocology Poulsbo Washington
United States CCOP - Kansas City Prairie Village Kansas
United States Cancer Center of Kansas, PA - Pratt Pratt Kansas
United States Good Samaritan Cancer Center Puyallup Washington
United States Reid Hospital & Health Care Services Richmond Indiana
United States Southern Regional Medical Center Riverdale Georgia
United States Harbin Clinic Cancer Center - Medical Oncology Rome Georgia
United States Rutherford Hospital Rutherfordton North Carolina
United States University of California Davis Cancer Center Sacramento California
United States Seton Cancer Institute at Saint Mary's - Saginaw Saginaw Michigan
United States Heartland Regional Medical Center Saint Joseph Missouri
United States Saint Joseph Oncology, Incorporated Saint Joseph Missouri
United States CCOP - St. Louis-Cape Girardeau Saint Louis Missouri
United States David C. Pratt Cancer Center at St. John's Mercy Saint Louis Missouri
United States Midwest Hematology Oncology Group, Incorporated Saint Louis Missouri
United States Saint Louis University Cancer Center Saint Louis Missouri
United States Cancer Center of Kansas, PA - Salina Salina Kansas
United States Tammy Walker Cancer Center at Salina Regional Health Center Salina Kansas
United States Huntsman Cancer Institute at University of Utah Salt Lake City Utah
United States Cancer Therapy and Research Center San Antonio Texas
United States University Hospital - San Antonio San Antonio Texas
United States University of Texas Health Science Center at San Antonio San Antonio Texas
United States Veterans Affairs Medical Center - San Antonio (Murphy) San Antonio Texas
United States California Pacific Medical Center - California Campus San Francisco California
United States New Mexico Cancer Care Associates Santa Fe New Mexico
United States Fred Hutchinson Cancer Research Center Seattle Washington
United States Group Health Central Hospital Seattle Washington
United States Harborview Medical Center Seattle Washington
United States Minor and James Medical, PLLC Seattle Washington
United States Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Seattle Washington
United States University Cancer Center at University of Washington Medical Center Seattle Washington
United States North Puget Oncology at United General Hospital Sedro-Woolley Washington
United States Welch Cancer Center at Sheridan Memorial Hospital Sheridan Wyoming
United States Feist-Weiller Cancer Center at Louisiana State University Health Sciences Shreveport Louisiana
United States Mercy Medical Center - Sioux City Sioux City Iowa
United States Siouxland Hematology-Oncology Associates, LLP Sioux City Iowa
United States St. Luke's Regional Medical Center Sioux City Iowa
United States Medical X-Ray Center, PC Sioux Falls South Dakota
United States Sanford Cancer Center at Sanford USD Medical Center Sioux Falls South Dakota
United States CCOP - Upstate Carolina Spartanburg South Carolina
United States Gibbs Regional Cancer Center at Spartanburg Regional 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 CCOP - Cancer Research for the Ozarks Springfield Missouri
United States Community Hospital of Springfield and Clark County Springfield Ohio
United States Hulston Cancer Center at Cox Medical Center South Springfield Missouri
United States Regional Cancer Center at Memorial Medical Center Springfield Illinois
United States St. John's Regional Health Center Springfield Missouri
United States Stanford Cancer Center Stanford California
United States Iredell Memorial Hospital Statesville North Carolina
United States Allenmore Hospital Tacoma Washington
United States CCOP - Northwest Tacoma Washington
United States Franciscan Cancer Center at St. Joseph Medical Center Tacoma Washington
United States Madigan Army Medical Center - Tacoma Tacoma Washington
United States MultiCare Regional Cancer Center at Tacoma General Hospital Tacoma Washington
United States St. Clare Hospital Tacoma Washington
United States Cotton-O'Neil Cancer Center Topeka Kansas
United States Munson Medical Center Traverse City Michigan
United States UVMC Cancer Care Center at Upper Valley Medical Center Troy Ohio
United States Arizona Cancer Center at University of Arizona Health Sciences Center Tucson Arizona
United States CCOP - Carle Cancer Center Urbana Illinois
United States Sutter Solano Medical Center Vallejo California
United States Northwest Cancer Specialists at Vancouver Cancer Center Vancouver Washington
United States Southwest Washington Medical Center Cancer Center Vancouver Washington
United States Maui Memorial Medical Center Wailuku Hawaii
United States Pacific Cancer Institute - Maui Wailuku Hawaii
United States St. John Macomb Hospital Warren Michigan
United States Cancer Center of Kansas, PA - Wellington Wellington Kansas
United States Wenatchee Valley Medical Center Wenatchee Washington
United States Mount Carmel St. Ann's Cancer Center Westerville Ohio
United States Associates in Womens Health, PA - North Review Wichita Kansas
United States Cancer Center of Kansas, PA - Medical Arts Tower Wichita Kansas
United States Cancer Center of Kansas, PA - Wichita Wichita Kansas
United States CCOP - Wichita Wichita Kansas
United States Via Christi Cancer Center at Via Christi Regional Medical Center Wichita Kansas
United States Wesley Medical Center Wichita Kansas
United States Cancer Center of Kansas, PA - Winfield Winfield Kansas
United States Ruth G. McMillan Cancer Center at Greene Memorial Hospital Xenia Ohio
United States Genesis - Good Samaritan Hospital Zanesville Ohio

Sponsors (3)

Lead Sponsor Collaborator
Southwest Oncology Group Eastern Cooperative Oncology Group, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Norwood TH, Gundacker HM, Slovak ML, et al.: Changes in the pattern of cytogenetic aberrations with advancing age in acute myeloid (Non-APL) leukemia: a Southwest Oncology study (S9007). [Abstract] Blood 108 (11): A-808, 2006.

Wolman SR, Gundacker HM, Slovak ML, et al.: Impact of trisomy 8(+8) on clinical presentation, treatment response, and survival in myeloid leukemia patients in Southwest Oncology Group (SWOG) trials. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-1125, 282a, 2001.

Outcome

Type Measure Description Time frame Safety issue
Primary Maintain and expand a database of cytogenetic information on leukemia patients. While protocol was open No
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