An Evaluation of a Multi-target Stool DNA (Mt-sDNA) Test, Cologuard, for CRC Screening in Individuals Aged 45-49 and at Average Risk for Development of Colorectal Cancer: Act Now

ID#: NCT03728348

Age: 45 - 49 years

Gender: All

Healthy Subjects: Accepts Healthy Volunteers

Recruitment Status: Recruiting

Start Date: November 06, 2018

End Date: July 01, 2019

Contact Information:
Alexandra Massoud
Shanna Allen

The primary objective is to confirm the specificity of a multi-target stool DNA test (mt-sDNA), Cologuard, in an average risk population, ages 45-49.


Inclusion Criteria: Subjects must meet the following criteria to be eligible for the study:

1. Subject is at average risk for development of CRC.

2. Subject is able and willing to undergo a screening colonoscopy.

3. Subject is ≥ 45 and ≤ 49 years of age at the time of enrollment.

4. Subject is willing and able to sign informed consent.

5. Subject is able and willing to provide stool sample(s) according to written instructions provided.

Exclusion Criteria:

1. Subject has a history of CRC or adenoma.

2. Subject has ≥2 first-degree relatives who have been diagnosed with CRC

3. Subject has one first-degree relative with CRC diagnosed before the age of 60.

4. Subject has any of the following: Overt rectal bleeding, e.g., hematochezia or melena within the previous 30 days (blood on toilet paper, after wiping, does not constitute rectal bleeding). Positive fecal occult blood test or FIT within the previous six (6) months. Subject has had a previous colonoscopy. Subject has undergone any double-contrast barium enema, virtual (CT-based) colonoscopy, or flexible sigmoidoscopy within the previous five (5) years.

5. Subject has a diagnosis or personal history of any of the following conditions, including: Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP and Gardner's syndrome). Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome").Other hereditary cancer syndromes including but are not limited to Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Neurofibromatosis and Familial Hyperplastic Polyposis.

6. Subject has a family history of: Familial adenomatous polyposis (also referred to as "FAP"), Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome").

7. Subjects with Cronkhite-Canada Syndrome.

8. Subject has a diagnosis of inflammatory bowel disease (IBD) including chronic ulcerative colitis (CUC) and Crohn's disease.

9. Subject has a history of aerodigestive tract cancer.

10. Subject has had a prior colorectal resection for any reason other than sigmoid diverticular disease.

11. Subject has any condition that in the opinion of the investigator should preclude participation in the study.