Colorectal CancerPRO-GENE-COLONNCT07621757
The Implementation of Genetic Risk for Colorectal Cancer Screening
An observational study of Colorectal Cancer and Colorectal Adenoma, run by Endeavor Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Colorectal Adenoma, Colorectal Polyp
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2026to 31 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older 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
Who may be able to join
- Due for initial screening colonoscopy per current guidelines
Who cannot join
- Prior colonoscopy
- Prior personal history of colorectal cancer or inflammatory bowel disease
- Medical contraindications to colonoscopy/sedation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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?
- Conditions
- Colorectal Cancer, Colorectal Adenoma, Colorectal Polyp
- Medical subject headings
- Colorectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of scheduled colonoscopies in each genetic risk group
Measured: One year following enrollment
Secondary outcomes (1)
Number of polyps and/or adenomas found through colonoscopy in each genetic risk group
Measured: One year following enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Endeavor Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianfeng Xu, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07621757
- Sponsor's protocol ID
- IRB2026-0064
- Acronym
- PRO-GENE-COLON
- Status last verified
- May 2026
- First submitted
- 22 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Trial for the Implementation of Genetic Risk for Colorectal Cancer Screening
- ClinicalTrials.gov ID
- NCT07621757
- Acronym / sponsor ID
- PRO-GENE-COLON / IRB2026-0064
- Conditions
- Colorectal Cancer, Colorectal Adenoma, Colorectal Polyp
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Endeavor HealthUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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
Key inclusion criteria (1 listed)
- Due for initial screening colonoscopy per current guidelines
Key exclusion criteria (3 listed)
- Prior colonoscopy
- Prior personal history of colorectal cancer or inflammatory bowel disease
- Medical contraindications to colonoscopy/sedation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of scheduled colonoscopies in each genetic risk group
Time frame: One year following enrollment
1 secondary outcome
Number of polyps and/or adenomas found through colonoscopy in each genetic risk group
Time frame: One year following enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Colorectal Adenoma, run by Endeavor Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of scheduled colonoscopies in each genetic risk group (time frame: One year following enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.