Longitudinal Performance of Epi proColon (PERT)

Epigenomics

Status: Unknown

Conditions: Colorectal Neoplasms; Colorectal Cancer

Treatments: Device: Epi proColon

Study type: Observational

Funder types: Industry

Identifiers

NCT03218423

SPR 0028

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4,500 estimated patients

Sex: All

Ages: 50 to 74 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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).

Exclusion criteria

• 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.