Multi-Target Colorectal Cancer Screening Test for the Detection of Colorectal Advanced Adenomatous Polyps and Cancer
DeeP-C
1 other identifier
observational
12,776
2 countries
184
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2011
184 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 18, 2011
CompletedFirst Posted
Study publicly available on registry
July 20, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedResults Posted
Study results publicly available
December 3, 2015
CompletedDecember 3, 2015
November 1, 2015
1.7 years
July 18, 2011
December 1, 2015
December 1, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Average risk patients
Subjects will be men and women, 50-84 years of age, inclusive, who are at average risk of developing colorectal cancer.
Eligibility Criteria
Patients at average risk of developing colorectal cancer.
You may not qualify if:
- Subject is able and willing to undergo a screening colonoscopy within 90 days of enrollment.
- Subject is 50 to 84 years of age inclusive.
- Subject is able to comprehend, sign, and date the written informed consent document to participate in the study.
- Subject is able and willing to provide stool samples according to written instructions provided to them.
- Subject has any condition which, in the opinion of the investigator should preclude participation in the study.
- Subject has undergone colonoscopy within the previous nine (9) years.
- Subject has undergone any double-contrast barium enema, virtual (CT-based) colonoscopy, or flexible sigmoidoscopy within the previous five (5) years.
- Subject has a history of colorectal cancer or adenoma.
- Subject has a history of aerodigestive tract cancer.
- Subject has had a positive fecal occult blood test or FIT within the previous six (6) months.
- Subject has had a prior colorectal resection for any reason other than sigmoid diverticular disease.
- 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).
- 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).
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (184)
Achieve Clinical Research
Birmingham, Alabama, 35216, United States
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259, United States
Desert Sun Clinical Research, LLC
Tucson, Arizona, 85710, United States
HealthCare Partners
Alhambra, California, 91801, United States
HealthCare Partners
Arcadia, California, 91006, United States
Valley Gastro Consultants
Arcadia, California, 91006, United States
Desert Oasis Healthcare
Bermuda Dunes, California, 92203, United States
HealthCare Partners
Burbank, California, 91506, United States
REMEK Research
Chino, California, 91710, United States
Southern California Oncology
Downey, California, 90241, United States
HealthCare Partners Medical Group
El Monte, California, 91733, United States
Southern California Oncology
Fullerton, California, 92835, United States
HealthCare Partners
Glendale, California, 91204, United States
HealthCare Partners
Glendale, California, 91208, United States
Valley Gastro Consultants
Glendora, California, 91741, United States
HealthCare Partners
Huntington Park, California, 90255, United States
Health Care Partners Medical Group
Long Beach, California, 90806, United States
Health Care Partners San Antonio
Long Beach, California, 90807, United States
VA Hospital
Long Beach, California, 90822, United States
Healthcare Partners Medical Group
Los Angeles, California, 90015, United States
HealthCare Partners
Los Angeles, California, 90043, United States
HealthCare Partners
Los Angeles, California, 90063, United States
Southern California Oncology
Lynwood, California, 90262, United States
Facey Medical Foundation
Mission Hills, California, 91345, United States
Healthcare Partners- Mission Plaza
Mission Hills, California, 91345, United States
Healthcare Partners-Mission Hills
Mission Hills, California, 91345, United States
REMEK Research
Montclair, California, 91763, United States
HealthCare Partners Medical Group
Montebello, California, 90640, United States
Monterey Bay GI Consultants Medical Group & Research Institute
Monterey, California, 93940, United States
Furtura Research
Monterey Park, California, 91754, United States
Healthcare Partners Medical Group
Monterey Park, California, 91754, United States
Diverse Research Solutions
Oxnard, California, 93030, United States
Desert Oasis Healthcare
Palm Springs, California, 92262, United States
Desert Regional Medical Center
Palm Springs, California, 92262, United States
HealthCare Partners
Pasadena, California, 91105, United States
REMEK Research
Pomona, California, 91767, United States
Health Care Partners
Redondo Beach, California, 90277, United States
Institute for Medical Research
Sacramento, California, 95816, United States
Sharp-Rees-Stealy Medical Group
San Diego, California, 92101, United States
Sharp-Rees-Stealy Medical Group
San Diego, California, 92123, United States
Sansum Clinic
Santa Barbara, California, 93105, United States
Sansum Clinic
Santa Barbara, California, 93110, United States
Santa Monica Research Institute
Santa Monica, California, 90404, United States
Health Care Partners Medical Group
Torrance, California, 90503, United States
South Bay Gastroenterology Medical Group
Torrance, California, 90505, United States
Tujunga Medical Group
Tujunga, California, 91042, United States
Healthcare Partners-Valencia
Valencia, California, 91355, United States
Healthcare Partners- Van Nuys
Van Nuys, California, 91405, United States
Southern California Oncology
Yorba Linda, California, 92886, United States
Gastroenterology Associates of Fairfield County
Bridgeport, Connecticut, 06606, United States
Gastroenterology Associates of Fairfield County
Fairfield, Connecticut, 06824, United States
Metropolitan Gastroenterology Group, PC
Washington D.C., District of Columbia, 20006, United States
Mayo Clinic Florida
Jacksonville, Florida, 32224, United States
Melbourne GI Center
Melbourne, Florida, 32901, United States
MIMA Century Research Associates
Melbourne, Florida, 32901, United States
Suncoast Research Group
Miami, Florida, 33135, United States
GI Care Center
Miami, Florida, 33173, United States
Gastro Health P.L.
Miami, Florida, 33176, United States
Miami Research Associates
South Miami, Florida, 33143, United States
Cancer Coalition of South Georgia
Albany, Georgia, 31707, United States
Phoebe Digestive Health Center
Albany, Georgia, 31707, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30308, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30318, United States
Atlanta Gastroenterology Associates
Hiram, Georgia, 30141, United States
Atlanta Gastroenterology Associates
Marietta, Georgia, 30060, United States
Atlanta Gastroenterology Associates
Marietta, Georgia, 30067, United States
Atlanta Gastroenterology Associates
Woodstock, Georgia, 30188, United States
NCH Medical Group
Arlington Heights, Illinois, 60004, United States
Northwest Community Hospital
Arlington Heights, Illinois, 60005, United States
NCH Medical Group
Buffalo Grove, Illinois, 60089, United States
Jesse Brown VAMC
Chicago, Illinois, 60612, United States
Union Health Services
Chicago, Illinois, 60612, United States
Union Health Services
Chicago, Illinois, 60652, United States
VA Hospital
Hines, Illinois, 60141, United States
Southwest Gastroenterology
New Lenox, Illinois, 60451, United States
Union Health Services
Norridge, Illinois, 60706, United States
Southwest Gastroenterology
Oak Lawn, Illinois, 60453, United States
Avicenna Clinical Research
Palos Heights, Illinois, 60463, United States
Rockford Gastroenterology Associates, LTD
Rockford, Illinois, 61107, United States
Roudebush VA Medical Center
Indianapolis, Indiana, 46202, United States
Iowa Digestive Disease Center
Clive, Iowa, 50325, United States
Gastroenterology & Nutritional Medical Services
Bastrop, Louisiana, 71220, United States
Gastroenterology Associates
Baton Rouge, Louisiana, 70809, United States
MGAGI Diagnostic and Therapeutic Center
Metairie, Louisiana, 70006, United States
New Orleans Research Institute
Metairie, Louisiana, 70006, United States
Delta Research Partners, LLC
Monroe, Louisiana, 71201, United States
Louisiana Research Center
Shreveport, Louisiana, 71103, United States
Digestive Disease Associates, PA
Baltimore, Maryland, 21229, United States
Gastrointestinal Diagnostic Center
Baltimore, Maryland, 21229, United States
Metropolitan Gastroenterology Group
Chevy Chase, Maryland, 20815, United States
Banks Hepatology Institute P.C.
College Park, Maryland, 20740, United States
Digestive Disease Associates
Columbia, Maryland, 21044, United States
Howard County GIDC
Columbia, Maryland, 21044, United States
Russell Schub
Columbia, Maryland, 21044, United States
Columbia Medical Practice
Columbia, Maryland, 21045, United States
Gasro Center of Maryland
Columbia, Maryland, 21045, United States
Gastro Center of Maryland
Columbia, Maryland, 21045, United States
Centennial Medical Group
Elkridge, Maryland, 21075, United States
Gastroenterology Associates
Elkridge, Maryland, 21075, United States
CBM Pathology
Gaithersburg, Maryland, 20879, United States
Maryland Digestive Disease Center
Laurel, Maryland, 20707, United States
Gastroenterology Associates
Pasadena, Maryland, 21122, United States
Boston Medical Center: Center for Digestive Disorders
Boston, Massachusetts, 02118, United States
Boston Medical Center: Family Medicine
Boston, Massachusetts, 02118, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Shapiro Ambulatory Care Center: Adult Primary Care
Boston, Massachusetts, 02118, United States
Shapiro Ambulatory Care Center: Women's Health Group
Boston, Massachusetts, 02118, United States
Commonwealth Clinical Studies PLLC
Brockton, Massachusetts, 02302, United States
Commonwealth Clinical Studies PLLC
East Bridgewater, Massachusetts, 02333, United States
Gastrointestinal Specialists
Taunton, Massachusetts, 02780, United States
Center for Digestive Health
Troy, Michigan, 48098, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
Advanced Research Institute
Reno, Nevada, 89511, United States
Summit Medical Group
Berkeley Heights, New Jersey, 07922, United States
AGA Clinical Research Associates, LLC
Egg Harbor, New Jersey, 08234, United States
Binghamton Gastroenterology
Binghamton, New York, 13903, United States
Gastrointestinal Research Group
Great Neck, New York, 11023, United States
Faculty Practice Associates
New York, New York, 10029, United States
GI Clinic
New York, New York, 10029, United States
Internal Medicine Associates
New York, New York, 10029, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
Practice Associates
New York, New York, 10029, United States
Digestive Health Specialists, PA
Advance, North Carolina, 27006, United States
Asheville Gastroenterology Associates
Asheville, North Carolina, 28801, United States
MediSpect
Boone, North Carolina, 28607, United States
Carolina Digestive Health Associates
Charlotte, North Carolina, 28262, United States
Carolina Digestive Health Associates
Concord, North Carolina, 28025, United States
Carolina Digestive Health Associates
Davidson, North Carolina, 28036, United States
Cumberland Research Associates
Fayetteville, North Carolina, 28304, United States
Carolina Digestive Health Associates
Harrisburg, North Carolina, 28075, United States
Digestive Health Specialists, PA
Kernersville, North Carolina, 27284, United States
Wake Research Associates
Raleigh, North Carolina, 27612, United States
Hanover Medical Specialists
Wilmington, North Carolina, 28401, United States
New Hanover Regional Medical Center
Wilmington, North Carolina, 28401, United States
Wilmington Gastroenterology Associates
Wilmington, North Carolina, 28403, United States
Digestive Health Specialists, PA
Winston-Salem, North Carolina, 27103, United States
Ohio GI & Liver Institute
Cincinnati, Ohio, 45014, United States
Consultants for Clinical Research
Cincinnati, Ohio, 45219, United States
Ohio GI & Liver Institute
Cincinnati, Ohio, 45219, United States
Northwest Gastroenterology Clinic, LLC
Portland, Oregon, 97210, United States
Main Line Gastroenterology
Bala-Cynwyd, Pennsylvania, 19004, United States
Regional Gastroenterology Associates of Lancaster
Ephrata, Pennsylvania, 17522, United States
Main Line Gastroenterology
Havertown, Pennsylvania, 19083, United States
Regional Gastroenterology Associates of Lancaster
Lancaster, Pennsylvania, 17604, United States
Main Line Gastroenterology
Malvern, Pennsylvania, 19355, United States
Main Line Gastroenterology
Media, Pennsylvania, 19063, United States
Main Line Gastroenterology
Perkasie, Pennsylvania, 18944, United States
PGC Endoscopy Center Inc.
Philadelphia, Pennsylvania, 19111, United States
Main Line Gastroenterology
Wynnewood, Pennsylvania, 19096, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464, United States
Gastroenterology Associates
Bristol, Tennessee, 37620, United States
Gastro One
Germantown, Tennessee, 38138, United States
Gastroenterology Associates of Clinical Research
Kingsport, Tennessee, 37660, United States
Professional Quality Research, Inc.
Austin, Texas, 78705, United States
Professional Quality Research, Inc.
Austin, Texas, 78745, United States
Professional Quality Research, Inc.
Austin, Texas, 78757, United States
Gastroenterology Associates, PA
Houston, Texas, 77034, United States
Advanced Clinical Research of Houston
Houston, Texas, 77062, United States
Houston Medical Research Associates
Houston, Texas, 77090, United States
Professional Quality Research, Inc.
Round Rock, Texas, 78681, United States
Digestive Health Specialists of Tyler
Tyler, Texas, 75701, United States
Advanced Research Institute
Logan, Utah, 84341, United States
Advanced Research Institute
Ogden, Utah, 84405, United States
Salt Lake Research, PLLC
Salt Lake City, Utah, 84107, United States
Advanced Research Institute
Sandy City, Utah, 84094, United States
Charlottesville Medical Research
Charlottesville, Virginia, 22911, United States
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, 23320, United States
Blue Ridge Medical Research
Lynchburg, Virginia, 24502, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, 23502, United States
Gastroenterology Associates of Tidewater
Norfolk, Virginia, 23505, United States
Clinical Research Associates of Tidewater
Norfolk, Virginia, 23507, United States
Lakeview Medical Center
Suffolk, Virginia, 23434, United States
Gastroenterology Associates of Tidewater
Virginia Beach, Virginia, 23462, United States
Northwest Gastroenterology Associates
Bellevue, Washington, 98004, United States
Marshfield Clinic-Eau Claire Center
Eau Claire, Wisconsin, 54701, United States
University of Wisconsin Milwaukee
Franklin, Wisconsin, 53132, United States
UW Health West Clinic
Madison, Wisconsin, 53717, United States
University of Wisconsin Madison
Madison, Wisconsin, 53792, United States
Marshfield Clinic
Marshfield, Wisconsin, 54449, United States
University of Wisconsin Milwaukee
Milwaukee, Wisconsin, 53215, United States
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, 54548, United States
Marshfield Clinic-Weston Center
Weston, Wisconsin, 54476, United States
University of Calgary
Calgary, Alberta, T2N 4Z6, Canada
Alberta Health Services
Calgary, Alberta, T2WIS7, Canada
Related Publications (3)
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.
PMID: 24645800RESULTImperiale TF, Gagrat ZD, Krockenberger M, Porter K, Ziegler E, Leduc CM, Matter MB, Olson MC, Limburg PJ. Algorithm Development and Early Performance Evaluation of a Next-Generation Multitarget Stool DNA Screening Test for Colorectal Cancer. Gastro Hep Adv. 2024 May 17;3(6):740-748. doi: 10.1016/j.gastha.2024.05.002. eCollection 2024.
PMID: 39280922DERIVEDEbner DW, Rushlow D, Mou J, Porter K, Finney Rutten LJ, Limburg P, Sancar F, Imperiale TF. Stool-Based Colorectal Cancer Screening Test Performance Characteristics in Those With and Without Hemorrhoids. Mayo Clin Proc Innov Qual Outcomes. 2023 Jul 19;7(4):320-326. doi: 10.1016/j.mayocpiqo.2023.06.003. eCollection 2023 Aug.
PMID: 37502338DERIVED
Biospecimen
Residual stool samples may be archived for further research. Clinical data and samples will be kept in a manner that preserves anonymity of the subjects, using the subject ID as the only tracking information. Specimens will be stored in a commercial biorepository contracted by Exact Sciences or at Exact Sciences and may be used for future research.
MeSH Terms
Conditions
Results Point of Contact
- Title
- Director of Clinical Operations
- Organization
- Exact Sciences
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Imperiale, MD
Principal Study Investigator
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2011
First Posted
July 20, 2011
Study Start
June 1, 2011
Primary Completion
February 1, 2013
Study Completion
May 1, 2013
Last Updated
December 3, 2015
Results First Posted
December 3, 2015
Record last verified: 2015-11