Last updated: October 29, 2021
Sponsor: Epigenomics, Inc
Overall Status: Active - Recruiting
Phase
N/A
Condition
Colon Cancer
Rectal Cancer
Cancer
Treatment
N/AClinical Study ID
NCT03218423
SPR 0028
Ages 50-74 All Genders Accepts Healthy Volunteers
Study Summary
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
Connect with a study center
Veterans Affairs San Diego Healthcare System
San Diego, California 92161
United StatesActive - Recruiting
Beaumont Health System
Royal Oak, Michigan 48073
United StatesActive - Recruiting
Rutgers University Hospital
New Brunswick, New Jersey 08901
United StatesActive - Recruiting
Duke University
Durham, North Carolina 27704
United StatesActive - Recruiting
Geisinger Health System
Danville, Pennsylvania 17822
United StatesActive - Recruiting
West Virginia University
Morgantown, West Virginia 26505
United StatesActive - Recruiting
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