Colorectal Cancer Clinical Trial
— DeeP-COfficial title:
Multi-Target Colorectal Cancer Screening Test for the Detection of Colorectal Advanced Adenomatous Polyps and Cancer: DeeP-C Study
Verified date | November 2015 |
Source | Exact Sciences Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Observational |
The primary objective is to determine the sensitivity and specificity of the Exact
Colorectal Cancer (CRC) screening test for colorectal cancer, using colonoscopy as the
reference method. Lesions will be confirmed as malignant by histopathologic examination.
The secondary objective is to compare the performance of the Exact CRC screening test to a
commercially available FIT assay, both with respect to cancer and advanced adenoma. Lesions
will be confirmed as malignant or precancerous by colonoscopy and histopathologic
examination.
Status | Completed |
Enrollment | 12776 |
Est. completion date | May 2013 |
Est. primary completion date | February 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 50 Years to 84 Years |
Eligibility |
Inclusion Criteria: 1. Subject is average risk for development of colorectal cancer (as defined by the inclusion and exclusion criteria below). 2. Subject is able and willing to undergo a screening colonoscopy within 90 days of enrollment. 3. Subject is 50 to 84 years of age inclusive. 4. Subject is able to comprehend, sign, and date the written informed consent document to participate in the study. 5. Subject is able and willing to provide stool samples according to written instructions provided to them. Exclusion Criteria: 1. Subject has any condition which, in the opinion of the investigator should preclude participation in the study. 2. Subject has undergone colonoscopy within the previous nine (9) years. 3. Subject has undergone any double-contrast barium enema, virtual (CT-based) colonoscopy, or flexible sigmoidoscopy within the previous five (5) years. 4. Subject has a history of colorectal cancer or adenoma. 5. Subject has a history of aerodigestive tract cancer. 6. Subject has had a positive fecal occult blood test or FIT within the previous six (6) months. 7. Subject has had a prior colorectal resection for any reason other than sigmoid diverticular disease. 8. Subject has had overt rectal bleeding, e.g., hematochezia or melena, within the previous 30 days. (Blood on toilet paper, after wiping, does not constitute rectal bleeding). 9. Subject has a diagnosis or personal history of any of the following high-risk conditions for colorectal cancer: - Inflammatory bowel disease (IBD) including chronic ulcerative colitis (CUC) and Crohn's disease. - >= 2 first-degree relatives who have been diagnosed with colon cancer. (Note: first-degree relatives include parents, siblings and offspring). - One first-degree relative with CRC diagnosed before the age of 60. - Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP). - Hereditary non-polyposis colorectal cancer syndrome (also referred to as "HNPCC" of "Lynch Syndrome"). - Other hereditary cancer syndromes including but are not limited to Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Gardner's Syndrome, Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Cronkhite-Canada Syndrome, Neurofibromatosis and Familial Hyperplastic Polyposis. 10. Subject has a family history of: - Familial adenomatous polyposis (also referred to as "FAP"). - Hereditary non-polyposis colorectal cancer syndrome (also referred to as "HNPCC" or "Lynch Syndrome"). 11. Participation in any "interventional" clinical study within the previous 30 days in which an experimental treatment is administered or might be administered through a randomized assignment of the subject to one or more study groups. |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Canada | Alberta Health Services | Calgary | Alberta |
Canada | University of Calgary | Calgary | Alberta |
United States | Digestive Health Specialists, PA | Advance | North Carolina |
United States | Cancer Coalition of South Georgia | Albany | Georgia |
United States | Phoebe Digestive Health Center | Albany | Georgia |
United States | HealthCare Partners | Alhambra | California |
United States | HealthCare Partners | Arcadia | California |
United States | Valley Gastro Consultants | Arcadia | California |
United States | NCH Medical Group | Arlington Heights | Illinois |
United States | Northwest Community Hospital | Arlington Heights | Illinois |
United States | Asheville Gastroenterology Associates | Asheville | North Carolina |
United States | Atlanta Gastroenterology Associates | Atlanta | Georgia |
United States | Atlanta Gastroenterology Associates | Atlanta | Georgia |
United States | Professional Quality Research, Inc. | Austin | Texas |
United States | Professional Quality Research, Inc. | Austin | Texas |
United States | Professional Quality Research, Inc. | Austin | Texas |
United States | Main Line Gastroenterology | Bala Cynwyd | Pennsylvania |
United States | Digestive Disease Associates, PA | Baltimore | Maryland |
United States | Gastrointestinal Diagnostic Center | Baltimore | Maryland |
United States | Gastroenterology & Nutritional Medical Services | Bastrop | Louisiana |
United States | Gastroenterology Associates | Baton Rouge | Louisiana |
United States | Northwest Gastroenterology Associates | Bellevue | Washington |
United States | Summit Medical Group | Berkeley Heights | New Jersey |
United States | Desert Oasis Healthcare | Bermuda Dunes | California |
United States | Binghamton Gastroenterology | Binghamton | New York |
United States | Achieve Clinical Research | Birmingham | Alabama |
United States | MediSpect | Boone | North Carolina |
United States | Boston Medical Center | Boston | Massachusetts |
United States | Boston Medical Center: Center for Digestive Disorders | Boston | Massachusetts |
United States | Boston Medical Center: Family Medicine | Boston | Massachusetts |
United States | Shapiro Ambulatory Care Center: Adult Primary Care | Boston | Massachusetts |
United States | Shapiro Ambulatory Care Center: Women's Health Group | Boston | Massachusetts |
United States | Gastroenterology Associates of Fairfield County | Bridgeport | Connecticut |
United States | Gastroenterology Associates | Bristol | Tennessee |
United States | Commonwealth Clinical Studies PLLC | Brockton | Massachusetts |
United States | NCH Medical Group | Buffalo Grove | Illinois |
United States | HealthCare Partners | Burbank | California |
United States | Carolina Digestive Health Associates | Charlotte | North Carolina |
United States | Charlottesville Medical Research | Charlottesville | Virginia |
United States | Gastroenterology Associates of Tidewater | Chesapeake | Virginia |
United States | Metropolitan Gastroenterology Group | Chevy Chase | Maryland |
United States | Jesse Brown VAMC | Chicago | Illinois |
United States | Union Health Services | Chicago | Illinois |
United States | Union Health Services | Chicago | Illinois |
United States | REMEK Research | Chino | California |
United States | Consultants for Clinical Research | Cincinnati | Ohio |
United States | Ohio GI & Liver Institute | Cincinnati | Ohio |
United States | Ohio GI & Liver Institute | Cincinnati | Ohio |
United States | Iowa Digestive Disease Center | Clive | Iowa |
United States | Banks Hepatology Institute P.C. | College Park | Maryland |
United States | Columbia Medical Practice | Columbia | Maryland |
United States | Digestive Disease Associates | Columbia | Maryland |
United States | Gasro Center of Maryland | Columbia | Maryland |
United States | Gastro Center of Maryland | Columbia | Maryland |
United States | Howard County GIDC | Columbia | Maryland |
United States | Russell Schub | Columbia | Maryland |
United States | Carolina Digestive Health Associates | Concord | North Carolina |
United States | Carolina Digestive Health Associates | Davidson | North Carolina |
United States | Southern California Oncology | Downey | California |
United States | Commonwealth Clinical Studies PLLC | East Bridgewater | Massachusetts |
United States | Marshfield Clinic-Eau Claire Center | Eau Claire | Wisconsin |
United States | AGA Clinical Research Associates, LLC | Egg Harbor Township | New Jersey |
United States | HealthCare Partners Medical Group | El Monte | California |
United States | Centennial Medical Group | Elkridge | Maryland |
United States | Gastroenterology Associates | Elkridge | Maryland |
United States | Regional Gastroenterology Associates of Lancaster | Ephrata | Pennsylvania |
United States | Gastroenterology Associates of Fairfield County | Fairfield | Connecticut |
United States | Cumberland Research Associates | Fayetteville | North Carolina |
United States | University of Wisconsin Milwaukee | Franklin | Wisconsin |
United States | Southern California Oncology | Fullerton | California |
United States | CBM Pathology | Gaithersburg | Maryland |
United States | Gastro One | Germantown | Tennessee |
United States | HealthCare Partners | Glendale | California |
United States | HealthCare Partners | Glendale | California |
United States | Valley Gastro Consultants | Glendora | California |
United States | Gastrointestinal Research Group | Great Neck | New York |
United States | Carolina Digestive Health Associates | Harrisburg | North Carolina |
United States | Main Line Gastroenterology | Havertown | Pennsylvania |
United States | VA Hospital | Hines | Illinois |
United States | Atlanta Gastroenterology Associates | Hiram | Georgia |
United States | Advanced Clinical Research of Houston | Houston | Texas |
United States | Gastroenterology Associates, PA | Houston | Texas |
United States | Houston Medical Research Associates | Houston | Texas |
United States | HealthCare Partners | Huntington Park | California |
United States | Roudebush VA Medical Center | Indianapolis | Indiana |
United States | Mayo Clinic Florida | Jacksonville | Florida |
United States | Digestive Health Specialists, PA | Kernersville | North Carolina |
United States | Gastroenterology Associates of Clinical Research | Kingsport | Tennessee |
United States | Regional Gastroenterology Associates of Lancaster | Lancaster | Pennsylvania |
United States | Maryland Digestive Disease Center | Laurel | Maryland |
United States | Advanced Research Institute | Logan | Utah |
United States | Health Care Partners Medical Group | Long Beach | California |
United States | Health Care Partners San Antonio | Long Beach | California |
United States | VA Hospital | Long Beach | California |
United States | HealthCare Partners | Los Angeles | California |
United States | HealthCare Partners | Los Angeles | California |
United States | Healthcare Partners Medical Group | Los Angeles | California |
United States | Blue Ridge Medical Research | Lynchburg | Virginia |
United States | Southern California Oncology | Lynwood | California |
United States | University of Wisconsin Madison | Madison | Wisconsin |
United States | UW Health West Clinic | Madison | Wisconsin |
United States | Main Line Gastroenterology | Malvern | Pennsylvania |
United States | Atlanta Gastroenterology Associates | Marietta | Georgia |
United States | Atlanta Gastroenterology Associates | Marietta | Georgia |
United States | Marshfield Clinic | Marshfield | Wisconsin |
United States | Main Line Gastroenterology | Media | Pennsylvania |
United States | Melbourne GI Center | Melbourne | Florida |
United States | MIMA Century Research Associates | Melbourne | Florida |
United States | MGAGI Diagnostic and Therapeutic Center | Metairie | Louisiana |
United States | New Orleans Research Institute | Metairie | Louisiana |
United States | Gastro Health P.L. | Miami | Florida |
United States | GI Care Center | Miami | Florida |
United States | Suncoast Research Group | Miami | Florida |
United States | University of Wisconsin Milwaukee | Milwaukee | Wisconsin |
United States | Marshfield Clinic-Minocqua Center | Minocqua | Wisconsin |
United States | Facey Medical Foundation | Mission Hills | California |
United States | Healthcare Partners- Mission Plaza | Mission Hills | California |
United States | Healthcare Partners-Mission Hills | Mission Hills | California |
United States | Delta Research Partners, LLC | Monroe | Louisiana |
United States | REMEK Research | Montclair | California |
United States | HealthCare Partners Medical Group | Montebello | California |
United States | Monterey Bay GI Consultants Medical Group & Research Institute | Monterey | California |
United States | Furtura Research | Monterey Park | California |
United States | Healthcare Partners Medical Group | Monterey Park | California |
United States | Coastal Carolina Research Center | Mt. Pleasant | South Carolina |
United States | Southwest Gastroenterology | New Lenox | Illinois |
United States | Faculty Practice Associates | New York | New York |
United States | GI Clinic | New York | New York |
United States | Internal Medicine Associates | New York | New York |
United States | Mount Sinai School of Medicine | New York | New York |
United States | Practice Associates | New York | New York |
United States | Mount Sinai School of Medicine | New York City | New York |
United States | Clinical Research Associates of Tidewater | Norfolk | Virginia |
United States | Digestive and Liver Disease Specialists | Norfolk | Virginia |
United States | Gastroenterology Associates of Tidewater | Norfolk | Virginia |
United States | Union Health Services | Norridge | Illinois |
United States | Southwest Gastroenterology | Oak Lawn | Illinois |
United States | Advanced Research Institute | Ogden | Utah |
United States | Diverse Research Solutions | Oxnard | California |
United States | Desert Oasis Healthcare | Palm Springs | California |
United States | Desert Regional Medical Center | Palm Springs | California |
United States | Avicenna Clinical Research | Palos Heights | Illinois |
United States | Gastroenterology Associates | Pasadena | Maryland |
United States | HealthCare Partners | Pasadena | California |
United States | Main Line Gastroenterology | Perkasie | Pennsylvania |
United States | PGC Endoscopy Center Inc. | Philadelphia | Pennsylvania |
United States | REMEK Research | Pomona | California |
United States | Northwest Gastroenterology Clinic, LLC | Portland | Oregon |
United States | Wake Research Associates | Raleigh | North Carolina |
United States | Health Care Partners | Redondo Beach | California |
United States | Advanced Research Institute | Reno | Nevada |
United States | Mayo Clinic Rochester | Rochester | Minnesota |
United States | Rockford Gastroenterology Associates, LTD | Rockford | Illinois |
United States | Professional Quality Research, Inc. | Round Rock | Texas |
United States | Institute for Medical Research | Sacramento | California |
United States | Salt Lake Research, PLLC | Salt Lake City | Utah |
United States | Sharp-Rees-Stealy Medical Group | San Diego | California |
United States | Sharp-Rees-Stealy Medical Group | San Diego | California |
United States | Advanced Research Institute | Sandy | Utah |
United States | Sansum Clinic | Santa Barbara | California |
United States | Sansum Clinic | Santa Barbara | California |
United States | Santa Monica Research Institute | Santa Monica | California |
United States | Mayo Clinic Scottsdale | Scottsdale | Arizona |
United States | Louisiana Research Center | Shreveport | Louisiana |
United States | Miami Research Associates | South Miami | Florida |
United States | Lakeview Medical Center | Suffolk | Virginia |
United States | Gastrointestinal Specialists | Taunton | Massachusetts |
United States | Health Care Partners Medical Group | Torrance | California |
United States | South Bay Gastroenterology Medical Group | Torrance | California |
United States | Center for Digestive Health | Troy | Michigan |
United States | Desert Sun Clinical Research, LLC | Tucson | Arizona |
United States | Tujunga Medical Group | Tujunga | California |
United States | Digestive Health Specialists of Tyler | Tyler | Texas |
United States | Healthcare Partners-Valencia | Valencia | California |
United States | Healthcare Partners- Van Nuys | Van Nuys | California |
United States | Gastroenterology Associates of Tidewater | Virginia Beach | Virginia |
United States | Metropolitan Gastroenterology Group, PC | Washington | District of Columbia |
United States | Marshfield Clinic-Weston Center | Weston | Wisconsin |
United States | Hanover Medical Specialists | Wilmington | North Carolina |
United States | New Hanover Regional Medical Center | Wilmington | North Carolina |
United States | Wilmington Gastroenterology Associates | Wilmington | North Carolina |
United States | Digestive Health Specialists, PA | Winston-Salem | North Carolina |
United States | Atlanta Gastroenterology Associates | Woodstock | Georgia |
United States | Main Line Gastroenterology | Wynnewood | Pennsylvania |
United States | Southern California Oncology | Yorba Linda | California |
Lead Sponsor | Collaborator |
---|---|
Exact Sciences Corporation |
United States, Canada,
Imperiale TF, Ransohoff DF, Itzkowitz SH, Levin TR, Lavin P, Lidgard GP, Ahlquist DA, Berger BM. Multitarget stool DNA testing for colorectal-cancer screening. N Engl J Med. 2014 Apr 3;370(14):1287-97. doi: 10.1056/NEJMoa1311194. Epub 2014 Mar 19. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sensitivity and Specificity of the Exact CRC Screening Test With Comparison to Colonoscopy, Both With Respect to Cancer. | An optical colonoscopic procedure is the reference method. Lesions will be confirmed as malignant by histopathologic examination. The DNA test includes quantitative molecular assays for KRAS mutations, aberrant NDRG4 and BMP3 methylation, and Beta-actin, plus a hemoglobin immunoassay. Results were generated with the use of a logistic-regression algorithm, with values of 183 or more considered to be positive. FIT values of more than 100 ng of hemoglobin per milliliter of buffer were considered to be positive. Tests were processed independently of colonoscopic findings. The test functions as a screening tool by generating a score, based on the detection of hemoglobin and multiple DNA methylation and mutational markers, together with an assessment of the total amount of human DNA in each sample. Sensitivity= 100*(multitarget DNA or FIT positive test/positive colonoscopy); Specificity= 100*(multitarget DNA or FIT negative test/negative colonoscopy). | 90 Days | No |
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