The Implementation of Genetic Risk for Colorectal Cancer Screening (PRO-GENE-COLON)

May 29, 2026 updated by: Jianfeng Xu, Endeavor Health

Prospective Trial for the Implementation of Genetic Risk for Colorectal Cancer Screening

The goal of this study is to investigate genetic risk for colorectal cancer utilizing polygenic risk scores (PRS) for adults over 45 who have not received their first colonoscopy. The main questions it hopes to address are:

How does knowledge of a patient's genetic risk for colorectal cancer affect the uptake of initial screening colonoscopies?
How do colonoscopy outcomes compare between genetic risk groups?

Study Overview

Status

Enrolling by invitation

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

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

Study Locations

United States
- Illinois
  - Evanston, Illinois, United States, 60201
    - Endeavor Health

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

Adult
Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Participants enrolled in the Genomic Health Initiative (GHI) at Endeavor Health in Illinois who meet the age requirements for screening colonoscopy and have consented to be recontacted for future non-GHI studies

Description

Inclusion Criteria:

- Due for initial screening colonoscopy per current guidelines

Exclusion Criteria:

Prior colonoscopy
Prior personal history of colorectal cancer or inflammatory bowel disease
Medical contraindications to colonoscopy/sedation

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of scheduled colonoscopies in each genetic risk group Time Frame: One year following enrollment	One year following enrollment

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of polyps and/or adenomas found through colonoscopy in each genetic risk group Time Frame: One year following enrollment	One year following enrollment

Collaborators and Investigators

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

Sponsor

Endeavor Health

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 (Estimated)

June 1, 2026

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

May 31, 2027

Study Registration Dates

First Submitted

May 22, 2026

First Submitted That Met QC Criteria

May 29, 2026

First Posted (Actual)

June 2, 2026

Study Record Updates

Last Update Posted (Actual)