The Implementation of Genetic Risk for Colorectal Cancer... | NCT07621757

Studies
The Implementation of Genetic Risk for Colorectal Cancer Screening

NCT07621757

Sponsor

Endeavor Health

Status

Enrolling by invitation

Last Update Posted

Jun 2, 2026Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Colorectal Cancer
Colorectal Adenoma
Colorectal Polyp

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2026Estimated

Primary Completion Date

Jan 31, 2027Estimated

Completion Date

May 31, 2027Estimated

First Submitted Date

May 22, 2026

First Submission Date that Met QC Criteria

May 29, 2026

First Posted Date

Jun 2, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 29, 2026

Last Update Posted Date

Jun 2, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jianfeng Xu, Vice President and Director, Genomic Translational Research, Endeavor HealthPrincipal Investigator

Lead Sponsor

Endeavor HealthOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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?

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Endeavor Health		Evanston	Illinois	60201	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided