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Longitudinal Performance of Epi proColon (PERT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03218423
Recruitment Status : Recruiting
First Posted : July 14, 2017
Last Update Posted : November 1, 2021
Information provided by (Responsible Party):
Epigenomics, Inc

Brief Summary:
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.

Condition or disease Intervention/treatment
Colorectal Cancer Colorectal Neoplasms Device: Epi proColon

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.

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Study Type : Observational
Estimated Enrollment : 4500 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Performance of Epi proColon in Repeated Testing in the Intended Use Population (PERT)
Actual Study Start Date : August 18, 2017
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : January 2024

Intervention Details:
  • Device: Epi proColon
    Plasma cell free DNA SEPT9 promoter methylation test for colorectal cancer screening.

Primary Outcome Measures :
  1. 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.

  2. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   50 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03218423

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Contact: Theo deVos, PhD 2068832916
Contact: Neil Mucci

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United States, California
Veterans Affairs San Diego Healthcare System Recruiting
San Diego, California, United States, 92161
Contact: Debora Goodman    858-552-8585 ext 6797   
Principal Investigator: Samir Gupta, MD         
United States, Michigan
Beaumont Health System Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Karen Barger-Smith    248-551-1556   
Contact: Maureen Cooney    248-551-0099   
Principal Investigator: Alexandra Halalau, MD         
United States, New Jersey
Rutgers University Hospital Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Marie Macor    732-235-8143   
Principal Investigator: Greg Riedlinger, MD, PhD         
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27704
Contact: Kim Leathers    919-668-5589   
Contact: Kathy Chmielewski    919-668-7863   
Principal Investigator: Ranee Chatterjee, MD         
United States, Pennsylvania
Geisinger Health System Recruiting
Danville, Pennsylvania, United States, 17822
Contact: Kay Reiner, MPH, BSN, RN    570-214-5421   
Principal Investigator: Amy Howell-Harte, MD         
United States, West Virginia
West Virginia University Recruiting
Morgantown, West Virginia, United States, 26505
Contact: Elyse Krupp    304-581-1913   
Principal Investigator: Dorian Williams, MD         
Sponsors and Collaborators
Epigenomics, Inc
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Study Director: Theo deVos, PhD Epigenomics, Inc
Additional Information:
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Responsible Party: Epigenomics, Inc Identifier: NCT03218423    
Other Study ID Numbers: SPR 0028
First Posted: July 14, 2017    Key Record Dates
Last Update Posted: November 1, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Epigenomics, Inc:
DNA methylation
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases