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

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:

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Colorectal Cancer; Colorectal Adenoma; Colorectal Polyp

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Endeavor Health

Study record dates

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): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: IRB2026-0064

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: No