Longitudinal Performance of Epi proColon

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Performance of Epi proColon in Repeated Testing in the Intended Use Population (PERT)

Conditions
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Colorectal Cancer, Colorectal Neoplasms

Intervention / Treatment
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* Device: Epi proColon


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Epi proColon|Plasma cell free DNA SEPT9 promoter methylation test for colorectal cancer screening.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference in test specificity between initial testing and repeat testing 1 year | Subjects will be tested with blood-based Epi proColon assay at initial enrollment, and tested again 1 year later (positive or negative test results) Subjects with positive test results with Epi proColon assay are referred to colonoscopy. Colonoscopy outcomes will be recorded (no evidence of disease or CRC) The difference in test specificity between initial and follow-up visits will be recorded. | Through study completion, expected at 60 months | 
| Detection of colorectal cancer | Findings of colorectal cancer in subjects with a colonoscopy following a positive Epi proColon test will be recorded. | Through study completion, expected at 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to testing | The adherence to repeated Epi proColon testing by patients who had a negative initial Epi proColon result will be recorded. | Through study completion, expected at 60 months | 
| Adherence to colonoscopy | The rate of adherence to colonoscopy for patients with a positive Epi proColon result will be recorded | Through study completion, expected at 60 months | 
| Diagnostic Yield | All procedure results will be recorded for patients who complete a colonoscopy evaluation following a positive Epi proColon test | Through study completion, expected at 60 months | 
| Assay Failure Rate | The Epi proColon assay failure rate will be recorded during the duration of the study | Through study completion, expected at 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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screening, plasma, DNA methylation