Recruiting

Epi proColonLongitudinal Performance of Epi proColon

Sponsor:

Epigenomics, Inc

Code:

NCT03218423

Conditions

Colorectal Cancer

Colorectal Neoplasms

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

Interventions

Epi proColon

Study Details

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.

Conditions

Colorectal Cancer

Colorectal Neoplasms

Study ID

NCT03218423

Start date

Aug 18, 2017

Status verified date

Oct, 2021

Completion date

Jan, 2024

Anticipated

Primary completion date

Aug, 2023

Anticipated

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

4500 participants

Anticipated

Interventions and Outcome Measures

Interventions

Epi proColon

Plasma cell free DNA SEPT9 promoter methylation test for colorectal cancer screening.

Primary outcome measure

The difference in test specificity between initial testing and repeat testing 1 year [ Time Frame: Through study completion, expected at 60 months ]
Detection of colorectal cancer [ Time Frame: Through study completion, expected at 60 months ]

Central Contacts and Locations

Central contacts

Theo deVos, PhD

2068832916 theo.devos@epigenomics.com

Neil Mucci

neil.mucci@globalbioclinical.com

Locations

Veterans Affairs San Diego Healthcare System

Recruiting

San Diego, California, United States, 92161

Contacts

Debora Goodman

858-552-8585 Debora.Goodman@va.gov

Principal Investigator:

Samir Gupta, MD

Beaumont Health System

Recruiting

Royal Oak, Michigan, United States, 48073

Contacts

Karen Barger-Smith

248-551-1556 karen.barger-smith@beaumont.org

Maureen Cooney

248-551-0099 maureen.cooney@beaumont.org

Principal Investigator:

Alexandra Halalau, MD

Rutgers University Hospital

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

Marie Macor

732-235-8143 macorma@rwjms.rutgers.edu

Principal Investigator:

Greg Riedlinger, MD, PhD

Duke University

Recruiting

Durham, North Carolina, United States, 27704

Contacts

Kim Leathers

919-668-5589 kimberly.leathers@duke.edu

Kathy Chmielewski

919-668-7863 kathy.chmielewski@duke.edu

Principal Investigator:

Ranee Chatterjee, MD

Geisinger Health System

Recruiting

Danville, Pennsylvania, United States, 17822

Contacts

Kay Reiner, MPH, BSN, RN

570-214-5421 kmreiner1@geisinger.edu

Principal Investigator:

Amy Howell-Harte, MD

West Virginia University

Recruiting

Morgantown, West Virginia, United States, 26505

Contacts

Elyse Krupp

304-581-1913 jennifer.krupp@hsc.wvu.edu

Principal Investigator:

Dorian Williams, MD

More Information

Sponsor

Epigenomics, Inc

Last update posted

Nov 1, 2021

Last verified

Oct, 2021

Keywords

screening
plasma
DNA methylation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Epigenomics, Inc on 2021-11-01.