Multi-Target Colorectal Cancer Screening Test for the Detection of Colorectal Advanced Adenomatous Polyps and Cancer

Completed

Conditions: Colonic Diseases
Colorectal Cancer
Digestive System Diseases
Colorectal Neoplasms

Registration Number: NCT01397747

Lead Sponsor: Exact Sciences Corporation

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.

Detailed Description: Patients who are at average risk of developing colorectal cancer who are eligible for colorectal cancer screening will be asked to collect a single stool sample for the Exact CRC screening test and for the commercially available FIT assay. Subjects will undergo colonoscopy within 90 days of enrollment. Representative histopathology slides from tissue biopsied or excised during colonoscopy and representative histopathology slides resulting from subsequent definitive surgery may be retrieved in order to be evaluated by central pathology to confirm diagnosis and staging.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 12776

Inclusion Criteria

Subject is average risk for development of colorectal cancer (as defined by the inclusion and exclusion criteria below).
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.

Exclusion Criteria

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).
- 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.
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").
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.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity and Specificity of the Exact CRC Screening Test With Comparison to Colonoscopy, Both With Respect to Cancer.	90 Days	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).

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (128): MIMA Century Research Associates
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Melbourne, Florida, United States
Gastrointestinal Diagnostic Center
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Baltimore, Maryland, United States
Howard County GIDC
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Columbia, Maryland, United States
Louisiana Research Center
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Shreveport, Louisiana, United States
Digestive Disease Associates, PA
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Baltimore, Maryland, United States
Russell Schub
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Columbia, Maryland, United States
Columbia Medical Practice
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Columbia, Maryland, United States
Gasro Center of Maryland
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Columbia, Maryland, United States
Healthcare Partners-Valencia
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Valencia, California, United States
Jesse Brown VAMC
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Chicago, Illinois, United States
Boston Medical Center: Center for Digestive Disorders
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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
Sharp-Rees-Stealy Medical Group
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San Diego, California, United States
Suncoast Research Group
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Miami, Florida, United States
GI Care Center
🇺🇸
Miami, Florida, United States
Gastro Health P.L.
🇺🇸
Miami, Florida, United States
Gastroenterology Associates, PA
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Houston, Texas, United States
Roudebush VA Medical Center
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Indianapolis, Indiana, United States
Advanced Clinical Research of Houston
🇺🇸
Houston, Texas, United States
Houston Medical Research Associates
🇺🇸
Houston, Texas, United States
Mayo Clinic Scottsdale
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Scottsdale, Arizona, United States
Desert Sun Clinical Research, LLC
🇺🇸
Tucson, Arizona, United States
HealthCare Partners
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Pasadena, California, United States
Valley Gastro Consultants
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Glendora, California, United States
Desert Oasis Healthcare
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Palm Springs, California, United States
REMEK Research
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Pomona, California, United States
Southern California Oncology
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Yorba Linda, California, United States
HealthCare Partners Medical Group
🇺🇸
Montebello, California, United States
Health Care Partners San Antonio
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Long Beach, California, United States
Health Care Partners Medical Group
🇺🇸
Torrance, California, United States
VA Hospital
🇺🇸
Hines, Illinois, United States
Healthcare Partners Medical Group
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Monterey Park, California, United States
Facey Medical Foundation
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Mission Hills, California, United States
Healthcare Partners- Mission Plaza
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Mission Hills, California, United States
Healthcare Partners-Mission Hills
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Mission Hills, California, United States
Sansum Clinic
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Santa Barbara, California, United States
Desert Regional Medical Center
🇺🇸
Palm Springs, California, United States
Monterey Bay GI Consultants Medical Group & Research Institute
🇺🇸
Monterey, California, United States
Diverse Research Solutions
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Oxnard, California, United States
Health Care Partners
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Redondo Beach, California, United States
Santa Monica Research Institute
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Santa Monica, California, United States
South Bay Gastroenterology Medical Group
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Torrance, California, United States
Tujunga Medical Group
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Tujunga, California, United States
Healthcare Partners- Van Nuys
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Van Nuys, California, United States
Gastroenterology Associates of Fairfield County
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Fairfield, Connecticut, United States
Melbourne GI Center
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Melbourne, Florida, United States
Mayo Clinic Florida
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Jacksonville, Florida, United States
Metropolitan Gastroenterology Group, PC
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Washington, District of Columbia, United States
Cancer Coalition of South Georgia
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Albany, Georgia, United States
Miami Research Associates
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South Miami, Florida, United States
Phoebe Digestive Health Center
🇺🇸
Albany, Georgia, United States
Atlanta Gastroenterology Associates
🇺🇸
Woodstock, Georgia, United States
Northwest Community Hospital
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Arlington Heights, Illinois, United States
NCH Medical Group
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Buffalo Grove, Illinois, United States
Union Health Services
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Norridge, Illinois, United States
Southwest Gastroenterology
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Oak Lawn, Illinois, United States
Rockford Gastroenterology Associates, LTD
🇺🇸
Rockford, Illinois, United States
Avicenna Clinical Research
🇺🇸
Palos Heights, Illinois, United States
Iowa Digestive Disease Center
🇺🇸
Clive, Iowa, United States
Gastroenterology Associates
🇺🇸
Bristol, Tennessee, United States
Gastroenterology & Nutritional Medical Services
🇺🇸
Bastrop, Louisiana, United States
MGAGI Diagnostic and Therapeutic Center
🇺🇸
Metairie, Louisiana, United States
New Orleans Research Institute
🇺🇸
Metairie, Louisiana, United States
Delta Research Partners, LLC
🇺🇸
Monroe, Louisiana, United States
Digestive Disease Associates
🇺🇸
Columbia, Maryland, United States
Metropolitan Gastroenterology Group
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Chevy Chase, Maryland, United States
Banks Hepatology Institute P.C.
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College Park, Maryland, United States
Gastro Center of Maryland
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Columbia, Maryland, United States
Centennial Medical Group
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Elkridge, Maryland, United States
CBM Pathology
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Gaithersburg, Maryland, United States
Maryland Digestive Disease Center
🇺🇸
Laurel, Maryland, United States
Boston Medical Center: Family Medicine
🇺🇸
Boston, Massachusetts, United States
Boston Medical Center
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Boston, Massachusetts, United States
Commonwealth Clinical Studies PLLC
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East Bridgewater, Massachusetts, United States
AGA Clinical Research Associates, LLC
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Egg Harbor Township, New Jersey, United States
Center for Digestive Health
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Troy, Michigan, United States
Summit Medical Group
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Berkeley Heights, New Jersey, United States
Gastrointestinal Specialists
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Taunton, Massachusetts, United States
Advanced Research Institute
🇺🇸
Sandy, Utah, United States
Binghamton Gastroenterology
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Binghamton, New York, United States
Gastrointestinal Research Group
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Great Neck, New York, United States
Mount Sinai School of Medicine
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New York, New York, United States
Faculty Practice Associates
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New York, New York, United States
GI Clinic
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New York, New York, United States
Internal Medicine Associates
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New York, New York, United States
Practice Associates
🇺🇸
New York, New York, United States
Asheville Gastroenterology Associates
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Asheville, North Carolina, United States
Wake Research Associates
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Raleigh, North Carolina, United States
Hanover Medical Specialists
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Wilmington, North Carolina, United States
New Hanover Regional Medical Center
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Wilmington, North Carolina, United States
Cumberland Research Associates
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Fayetteville, North Carolina, United States
Wilmington Gastroenterology Associates
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Wilmington, North Carolina, United States
MediSpect
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Boone, North Carolina, United States
Carolina Digestive Health Associates
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Harrisburg, North Carolina, United States
PGC Endoscopy Center Inc.
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Philadelphia, Pennsylvania, United States
Coastal Carolina Research Center
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Mt. Pleasant, South Carolina, United States
Ohio GI & Liver Institute
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Cincinnati, Ohio, United States
Consultants for Clinical Research
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Cincinnati, Ohio, United States
Main Line Gastroenterology
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Wynnewood, Pennsylvania, United States
Regional Gastroenterology Associates of Lancaster
🇺🇸
Lancaster, Pennsylvania, United States
Gastro One
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Germantown, Tennessee, United States
Gastroenterology Associates of Clinical Research
🇺🇸
Kingsport, Tennessee, United States
Professional Quality Research, Inc.
🇺🇸
Round Rock, Texas, United States
Digestive Health Specialists of Tyler
🇺🇸
Tyler, Texas, United States
Charlottesville Medical Research
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Charlottesville, Virginia, United States
Gastroenterology Associates of Tidewater
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Virginia Beach, Virginia, United States
Blue Ridge Medical Research
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Lynchburg, Virginia, United States
Clinical Research Associates of Tidewater
🇺🇸
Norfolk, Virginia, United States
Digestive and Liver Disease Specialists
🇺🇸
Norfolk, Virginia, United States
Northwest Gastroenterology Associates
🇺🇸
Bellevue, Washington, United States
Lakeview Medical Center
🇺🇸
Suffolk, Virginia, United States
Marshfield Clinic-Eau Claire Center
🇺🇸
Eau Claire, Wisconsin, United States
UW Health West Clinic
🇺🇸
Madison, Wisconsin, United States
Marshfield Clinic
🇺🇸
Marshfield, Wisconsin, United States
University of Wisconsin Madison
🇺🇸
Madison, Wisconsin, United States
Marshfield Clinic-Minocqua Center
🇺🇸
Minocqua, Wisconsin, United States
Marshfield Clinic-Weston Center
🇺🇸
Weston, Wisconsin, United States
University of Calgary
🇨🇦
Calgary, Alberta, Canada
Alberta Health Services
🇨🇦
Calgary, Alberta, Canada
Achieve Clinical Research
🇺🇸
Birmingham, Alabama, United States
Institute for Medical Research
🇺🇸
Sacramento, California, United States
Mayo Clinic Rochester
🇺🇸
Rochester, Minnesota, United States
Digestive Health Specialists, PA
🇺🇸
Winston-Salem, North Carolina, United States
Northwest Gastroenterology Clinic, LLC
🇺🇸
Portland, Oregon, United States
Salt Lake Research, PLLC
🇺🇸
Salt Lake City, Utah, United States
University of Wisconsin Milwaukee
🇺🇸
Milwaukee, Wisconsin, United States
Furtura Research
🇺🇸
Monterey Park, California, United States