Status:
COMPLETED
Multi-Target Colorectal Cancer Screening Test for the Detection of Colorectal Advanced Adenomatous Polyps and Cancer
Lead Sponsor:
Exact Sciences Corporation
Conditions:
Colorectal Neoplasms
Digestive System Diseases
Eligibility:
All Genders
50-84 years
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...
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 fo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
12776 Patients enrolled
Trial Details
Trial ID
NCT01397747
Start Date
June 1 2011
End Date
May 1 2013
Last Update
December 3 2015
Active Locations (184)
Enter a location and click search to find clinical trials sorted by distance.
1
Achieve Clinical Research
Birmingham, Alabama, United States, 35216
2
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259
3
Desert Sun Clinical Research, LLC
Tucson, Arizona, United States, 85710
4
HealthCare Partners
Alhambra, California, United States, 91801