Act Now Study: An Evaluation of a Multi-target Stool DNA (mt-sDNA) Test, Cologuard, for CRC Screening in Asymptomatic Individuals Aged 45-49 and at Average Risk for Development of Colorectal Cancer
Thomas Imperiale, MD
Primary Investigator
Overview
The purpose of this research is to determine the ability of the Exact Sciences CRC stool screening test to accurately and reliably detect colorectal cancer and pre-cancer in subjects aged 45-49 years when compared with a colonoscopy procedure.
Description
The Act Now Study wants to find out if the stool test can become a colon cancer screening option for 45-49 year olds, by comparing it with a colonoscopy.
Eligibility
You may be eligible for this study if you meet the following criteria:
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Conditions:
Colorectal Cancer, Healthy
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Age: Between 45 Years - 49 Years
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Gender: All
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 asymptomatic with respect to those symptoms that would ordinarily result in a colonoscopy to rule out CRC or clinical work-up for gastrointestinal pathology or disease.
3. Subject is 45-49 years of age at the time of enrollment through expected study completion, approximately 60 days after enrollment.
4. Subject is willing and able to sign informed consent.
Exclusion Criteria
Subjects presenting with any of the following will not be included in the study:
1. Subject has a personal history of CRC.
2. Subject has ≥2 first-degree relatives who have been diagnosed with colon cancer.
3. Subject has a 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 (blood on toilet paper, after wiping, does not constitute rectal bleeding).
• Unexplained iron deficiency anemia with a severity that would indicate a workup for gastrointestinal bleeding within the previous six (6) months.
• Positive fecal occult blood test or FIT within the previous six (6) months.
• Subject has had a previous colonoscopy.
5. Subject has a known syndromic hereditary condition (FAP, HNPC, etc.) or has a documented first degree relative with a known heritable cancer syndrome, 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. Subjects with Cronkhite-Canada Syndrome.
7. Subject has a diagnosis or personal history of inflammatory bowel disease (IBD) including chronic ulcerative colitis (CUC) and Crohn's disease.
8. Subject has a history of non-colorectal aerodigestive tract cancer.
9. Subject has had a prior colorectal resection for any reason other than sigmoid diverticular disease.
10. Subject has any condition that in the opinion of the investigator should preclude participation in the study.
