Longitudinal Performance of Epi proColon

Last updated: October 29, 2021
Sponsor: Epigenomics, Inc
Overall Status: Active - Recruiting

Phase

N/A

Condition

Colon Cancer

Rectal Cancer

Cancer

Treatment

N/A

Clinical Study ID

NCT03218423
SPR 0028
  • Ages 50-74
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Average-risk subjects (no family history of colorectal cancer (CRC), no personalhistory 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 colonoscopyand 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).

Exclusion

Exclusion Criteria:

  • Subjects defined as having elevated risk for developing CRC based on previous historyof colorectal polyps, CRC or related cancers, inflammatory bowel disease (IBD).
  • Subjects with a family history of CRC, particularly with two or more first degreerelatives with CRC, or one or more first degree relative(s) less than 50 years of agewith CRC.
  • Subjects who have been diagnosed with a relevant familial (hereditary) cancersyndrome, such as familial adenomatous polyposis (FAP) or non-polyposis colorectalcancer (HNPCC or Lynch Syndrome), Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Gardner's syndrome, Turcot's (or Crail's) syndrome, Cowden's syndrome, JuvenilePolyposis, Cronkhite-Canada syndrome, Neurofibromatosis, or Familial HyperplasticPolyposis, or in patients with anorectal bleeding, hematochezia, or with known irondeficiency 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 colonoscopywithin 10 years).
  • Subjects with comorbid illness precluding endoscopic evaluation (coronary arterydisease with myocardial infarction within 6 months, unstable angina or congestiveheart failure, chronic obstructive pulmonary disease requiring home oxygen, otherdiseases that limit life expectancy to less than 10 years).
  • Subjects with chronic gastritis, or who have cancer other than colorectal, or pregnantwomen.

Study Design

Total Participants: 4500
Study Start date:
August 18, 2017
Estimated Completion Date:
January 31, 2024

Study Description

Epi proColon is blood based screening test for colorectal cancer that is FDA - PMA approved. It is indicated for average risk patients who are unwilling or unable to be screened with other recommended screening tests, including colonoscopy or fecal occult blood tests.

The PERT study is designed to assess the test performance of Epi proColon when it is used annually for two consecutive years. Subjects enrolled in the study will be offered initial testing. Subjects with a positive result will be referred for colonoscopy. Subjects with a negative test result will be encouraged to be screened the following year. At the one year interval, test negative subjects will be reminded to be rescreened. Subjects with a positive test will be referred for colonoscopy, while subjects with a negative test will be be encouraged to participate in a screening program in subsequent years.

Connect with a study center

  • Veterans Affairs San Diego Healthcare System

    San Diego, California 92161
    United States

    Active - Recruiting

  • Beaumont Health System

    Royal Oak, Michigan 48073
    United States

    Active - Recruiting

  • Rutgers University Hospital

    New Brunswick, New Jersey 08901
    United States

    Active - Recruiting

  • Duke University

    Durham, North Carolina 27704
    United States

    Active - Recruiting

  • Geisinger Health System

    Danville, Pennsylvania 17822
    United States

    Active - Recruiting

  • West Virginia University

    Morgantown, West Virginia 26505
    United States

    Active - Recruiting

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