Longitudinal Performance of Epi proColon



Status:Recruiting
Conditions:Colorectal Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:50 - 74
Updated:2/16/2018
Start Date:August 18, 2017
End Date:January 2022
Contact:Theo deVos, PhD
Email:theo.devos@epigenomics.com
Phone:2068832916

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

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.

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.

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.
We found this trial at
6
sites
Danville, Pennsylvania 17822
Principal Investigator: Amy Howell-Harte, MD
Phone: 570-214-5421
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Durham, North Carolina 27710
(919) 684-8111
Principal Investigator: Ranee Chatterjee, MD
Phone: 919-668-5589
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Morgantown, West Virginia 26506
(304) 293-0111
Principal Investigator: Dorian Williams, MD
Phone: 304-581-1978
West Virginia University West Virginia University, founded in 1867, has a long and rich history...
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New Brunswick, New Jersey 08903
Principal Investigator: Chen Liu, MD
Phone: 732-947-1021
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New Brunswick, NJ
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Royal Oak, Michigan 48073
Principal Investigator: Alexandra Halalau, MD
Phone: 248-551-1556
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San Diego, California 92161
Principal Investigator: Samir Gupta, MD
Phone: 858-552-8585
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San Diego, CA
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