Clinical Validation of An Optimized Multi-Target Stool DNA (Mt-sDNA 2.0) Test, for Colorectal Cancer Screening "BLUE-C"

Completed

Conditions studied: Colorectal Cancer

In brief

The primary objective of this study is to assess the sensitivity for colorectal cancer (CRC) and specificity of the mt-sDNA 2.0 test.

Key facts

Study ID

NCT04144738

Run by

Exact Sciences Corporation

People needed

26758

Starts

2019-11-15

Expected to finish

2023-03-30

Last updated by the study team

2023-09-01

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects must meet the following criteria to be eligible for the study:
• Subject is ≥ 40 years of age at the time of enrollment.
• Subject presents for a screening colonoscopy per standard of care.
• Subject has no symptoms or signs that require immediate, or near term, referral for diagnostic or therapeutic colonoscopy.
• Subject is able and willing to sign informed consent

You may not qualify if…

• Subject has a history of CRC or advanced precancerous lesions.
• Subject has a diagnosis or medical / family 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, or Familial Hyperplastic Polyposis.
• Subject has a diagnosis or personal history of inflammatory bowel disease (IBD) including chronic ulcerative colitis and/or Crohn's disease.
• Subject has a diagnosis of Cronkhite-Canada Syndrome.
• Subject has had a positive Cologuard within the previous 2 years, or fecal occult blood test or FIT within the previous 6 months.
• Subject has undergone a colonoscopy within the previous 9 years with the exception of a failed colonoscopy due to poor bowel preparation. Failed colonoscopy must have been within the past year and without therapeutic intervention.
• Subject has had overt rectal bleeding within the previous 30 days.
• Subject has any condition that in the opinion of the Investigator should preclude participation in the study.

Where it is running

• Summit Internal Medicine, PC — Birmingham, Alabama, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Cullman Clinical Trials — Cullman, Alabama, United States
• Digestive Health Specialists of the Southeast — Dothan, Alabama, United States
• G & L Research — Foley, Alabama, United States
• Medical Affiliated Research Center — Huntsville, Alabama, United States
• East View Medical Research, LLC — Mobile, Alabama, United States
• GI Associates of West Alabama, P.C — Tuscaloosa, Alabama, United States
• Mayo Clinic - AZ — Phoenix, Arizona, United States
• Del Sol Research Management, LLC — Tucson, Arizona, United States
• Southern Arizona VA Health Care System (SAVAHCS) — Tucson, Arizona, United States
• Lynn Institute of the Ozarks — Little Rock, Arkansas, United States
• Applied Research Center of Arkansas — Little Rock, Arkansas, United States
• Arkansas Gastroenterology, P.A. — North Little Rock, Arkansas, United States
• Fomat Medical Research — Camarillo, California, United States
• Alliance Research Institute — Canoga Park, California, United States
• GW Research Inc — Chula Vista, California, United States
• Paragon Rx Clinical, Inc. — Garden Grove, California, United States
• United Medical Doctors — Irvine, California, United States
• Prime Care Clinical Research Center — Laguna Hills, California, United States
• Gastro Care Institute — Lancaster, California, United States
• Facey Medical Foundation — Mission Hills, California, United States
• Knowledge Research Center — Orange, California, United States
• Desert Oasis Healthcare Medical Group — Palm Springs, California, United States
• Parkway Medical Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.