Longitudinal Performance of Epi proColon

Status unconfirmed

Conditions studied: Colorectal Cancer, Colorectal Neoplasms

In brief

This study will evaluate longitudinal performance of Epi proColon with respect to test positivity, longitudinal adherence to Epi proColon screening, adherence to follow-up colonoscopy and diagnostic yield, as well as assay failure rates.

Key facts

Study ID

NCT03218423

Run by

Epigenomics, Inc

People needed

4500

Starts

2017-08-18

Expected to finish

2024-01-01

Last updated by the study team

2021-11-01

Who can join

Age: 50 and older, up to 74. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Average-risk subjects (no family history of colorectal cancer (CRC), no personal history of polyps or CRC).
• Subjects who have a history of non-compliance for CRC screening.
• After proper counseling by a health care provider, subjects who declined colonoscopy and FIT testing.
• Subjects who are 50 years of age or greater, but less than 75 years old.
• Subjects who are able to understand and sign written informed consent (IC).

You may not qualify if…

• Subjects defined as having elevated risk for developing CRC based on previous history of colorectal polyps, CRC or related cancers, inflammatory bowel disease (IBD).
• Subjects with a family history of CRC, particularly with two or more first degree relatives with CRC, or one or more first degree relative(s) less than 50 years of age with CRC.
• Subjects who have been diagnosed with a relevant familial (hereditary) cancer syndrome, such as familial adenomatous polyposis (FAP) or non-polyposis colorectal cancer (HNPCC or Lynch Syndrome), 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, or Familial Hyperplastic Polyposis, or in patients with anorectal bleeding, hematochezia, or with known iron deficiency anemia.
• Subjects who are up to date for CRC screening (FOBT within preceding 12 months, flexible sigmoidoscopy or double contrast barium enema within 5 years, or colonoscopy within 10 years).
• Subjects with comorbid illness precluding endoscopic evaluation (coronary artery disease with myocardial infarction within 6 months, unstable angina or congestive heart failure, chronic obstructive pulmonary disease requiring home oxygen, other diseases that limit life expectancy to less than 10 years).
• Subjects with chronic gastritis, or who have cancer other than colorectal, or pregnant women.

Where it is running

• Veterans Affairs San Diego Healthcare System — San Diego, California, United States (enrolling)
• Beaumont Health System — Royal Oak, Michigan, United States (enrolling)
• Rutgers University Hospital — New Brunswick, New Jersey, United States (enrolling)
• Duke University — Durham, North Carolina, United States (enrolling)
• Geisinger Health System — Danville, Pennsylvania, United States (enrolling)
• West Virginia University — Morgantown, West Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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