NCT07621757

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
12mo left

Started Jun 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Study Progress4%
Jun 2026May 2027

First Submitted

Initial submission to the registry

May 22, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Last Updated

June 2, 2026

Status Verified

May 1, 2026

Enrollment Period

8 months

First QC Date

May 22, 2026

Last Update Submit

May 29, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of scheduled colonoscopies in each genetic risk group

    One year following enrollment

Secondary Outcomes (1)

  • Number of polyps and/or adenomas found through colonoscopy in each genetic risk group

    One year following enrollment

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • \- Due for initial screening colonoscopy per current guidelines

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Endeavor Health

Evanston, Illinois, 60201, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva samples will be collected for DNA sequencing

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice President and Director, Genomic Translational Research

Study Record Dates

First Submitted

May 22, 2026

First Posted

June 2, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

May 31, 2027

Last Updated

June 2, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations