Longitudinal Performance of Epi proColon (PERT)

October 29, 2021 updated by: Epigenomics, Inc

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

4500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92161
        • Recruiting
        • Veterans Affairs San Diego Healthcare System
        • Contact:
        • Principal Investigator:
          • Samir Gupta, MD
    • Michigan
      • Royal Oak, Michigan, United States, 48073
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Rutgers University Hospital
        • Contact:
        • Principal Investigator:
          • Greg Riedlinger, MD, PhD
    • North Carolina
      • Durham, North Carolina, United States, 27704
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Recruiting
        • Geisinger Health System
        • Contact:
        • Principal Investigator:
          • Amy Howell-Harte, MD
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • Recruiting
        • West Virginia University
        • Contact:
        • Principal Investigator:
          • Dorian Williams, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population will be the population defined in the intended use statement, i.e. adults of either sex, 50 years or older, defined as average risk for CRC, who have been offered and have a history of not completing CRC screening. Tests that are available and recommended in the USPSTF 2008 CRC screening guidelines will be offered and declined prior to offering the Epi proColon test.

Eligible subjects will be recruited at a regular visit at their primary health care provider, or through typical preventive care outreach by health care providers. Consented subjects who agree to participate in the study and agree to be tested with Epi proColon will be enrolled.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The difference in test specificity between initial testing and repeat testing 1 year
Time Frame: Through study completion, expected at 60 months
  • 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
Time Frame: Through study completion, expected at 60 months
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
Time Frame: Through study completion, expected at 60 months
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
Time Frame: Through study completion, expected at 60 months
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
Time Frame: Through study completion, expected at 60 months
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
Time Frame: Through study completion, expected at 60 months
The Epi proColon assay failure rate will be recorded during the duration of the study
Through study completion, expected at 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Epigenomics, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 18, 2017

Primary Completion (Anticipated)

August 1, 2023

Study Completion (Anticipated)

January 1, 2024

Study Registration Dates

First Submitted

June 14, 2017

First Submitted That Met QC Criteria

July 12, 2017

First Posted (Actual)

July 14, 2017

Study Record Updates

Last Update Posted (Actual)

November 1, 2021

Last Update Submitted That Met QC Criteria

October 29, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPR 0028

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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