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

Completed

Conditions studied: Colorectal Cancer

In brief

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.

Key facts

Study ID

NCT03728348

Run by

Exact Sciences Corporation

People needed

983

Starts

2018-11-06

Expected to finish

2019-06-18

Last updated by the study team

2021-06-04

Who can join

Age: 45 and older, up to 49. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects must meet the following criteria to be eligible for the study:
• Subject is at average risk for development of CRC.
• Subject is able and willing to undergo a screening colonoscopy.
• Subject is ≥ 45 and ≤ 49 years of age at the time of enrollment.
• Subject is willing and able to sign informed consent.
• Subject is able and willing to provide stool sample(s) according to written instructions provided.

You may not qualify if…

• Subject has a history of CRC or adenoma.
• Subject has ≥2 first-degree relatives who have been diagnosed with CRC
• Subject has one first-degree relative with CRC diagnosed before the age of 60.
• 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.
• 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.
• 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").
• Subjects with Cronkhite-Canada Syndrome.
• Subject has a diagnosis of inflammatory bowel disease (IBD) including chronic ulcerative colitis (CUC) and Crohn's disease.
• Subject has a history of aerodigestive tract cancer.
• Subject has had a prior colorectal resection for any reason other than sigmoid diverticular disease.
• Subject has any condition that in the opinion of the investigator should preclude participation in the study.

Where it is running

• Mayo Clinic Arizona — Phoenix, Arizona, United States
• Ventura County Gastroenterology — Camarillo, California, United States
• Alliance Research Centers — Laguna Hills, California, United States
• Focilmed — Oxnard, California, United States
• Desert Oasis Healthcare Medical Group — Palm Springs, California, United States
• Gastroenterology Associates of Fairfield County — Bridgeport, Connecticut, United States
• Yale University Section of Digestive Diseases and Liver Diseases — New Haven, Connecticut, United States
• Precision Clinical Research, LLC — Lauderdale Lakes, Florida, United States
• Northshore University Health System Evanston Hospital — Evanston, Illinois, United States
• DM Clinical Research- Southwest Gastroenterology — Oak Lawn, Illinois, United States
• Deaconess Clinic- Mt. Pleasant — Evansville, Indiana, United States
• Indiana University, Eskanazi Hospital — Indianapolis, Indiana, United States
• Deaconess Clinic- Gateway — Newburgh, Indiana, United States
• Johnson County ClinTrials, LLC — Lenexa, Kansas, United States
• New Orleans Research Institute — Metairie, Louisiana, United States
• Delta Research Partners, LLC — Monroe, Louisiana, United States
• Louisiana Research Center — Shreveport, Louisiana, United States
• Investigative Clinical Research — Annapolis, Maryland, United States
• Centennial Medical Group — Elkridge, Maryland, United States
• Capitol Research — Rockville, Maryland, United States
• Commonwealth Clinical Studies — Brockton, Massachusetts, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• United Medical Associates — Binghamton, New York, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Asheville Gastroenterology Associates — Asheville, North Carolina, United States

Full record on ClinicalTrials.gov

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