NCT03218423

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2017

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 14, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

August 18, 2017

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

November 1, 2021

Status Verified

October 1, 2021

Enrollment Period

6 years

First QC Date

June 14, 2017

Last Update Submit

October 29, 2021

Conditions

Colorectal CancerColorectal Neoplasms

Keywords

screeningplasmaDNA methylation

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Adherence to testing

    Through study completion, expected at 60 months

  • Adherence to colonoscopy

    Through study completion, expected at 60 months

  • Diagnostic Yield

    Through study completion, expected at 60 months

  • Assay Failure Rate

    Through study completion, expected at 60 months

Interventions

Epi proColonDEVICE

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

Eligibility Criteria

Age50 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Veterans Affairs San Diego Healthcare System

San Diego, California, 92161, United States

RECRUITING

Beaumont Health System

Royal Oak, Michigan, 48073, United States

RECRUITING

Rutgers University Hospital

New Brunswick, New Jersey, 08901, United States

RECRUITING

Duke University

Durham, North Carolina, 27704, United States

RECRUITING

Geisinger Health System

Danville, Pennsylvania, 17822, United States

RECRUITING

West Virginia University

Morgantown, West Virginia, 26505, United States

RECRUITING

Related Publications (2)

  • Potter NT, Hurban P, White MN, Whitlock KD, Lofton-Day CE, Tetzner R, Koenig T, Quigley NB, Weiss G. Validation of a real-time PCR-based qualitative assay for the detection of methylated SEPT9 DNA in human plasma. Clin Chem. 2014 Sep;60(9):1183-91. doi: 10.1373/clinchem.2013.221044. Epub 2014 Jun 17.

    PMID: 24938752BACKGROUND

  • Johnson DA, Barclay RL, Mergener K, Weiss G, Konig T, Beck J, Potter NT. Plasma Septin9 versus fecal immunochemical testing for colorectal cancer screening: a prospective multicenter study. PLoS One. 2014 Jun 5;9(6):e98238. doi: 10.1371/journal.pone.0098238. eCollection 2014.

    PMID: 24901436BACKGROUND

Related Links

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Theo deVos, PhD

    Epigenomics, Inc

    STUDY DIRECTOR

Central Study Contacts

Theo deVos, PhD

CONTACT

2068832916theo.devos@epigenomics.com

Neil Mucci

CONTACT

neil.mucci@globalbioclinical.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2017

First Posted

July 14, 2017

Study Start

August 18, 2017

Primary Completion

August 1, 2023

Study Completion

January 1, 2024

Last Updated

November 1, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

US(6)