Actively Recruiting
Pathways, Risk Factors, and mOleculeS to Prevent Early-onset Colorectal Tumors
Led by Massachusetts General Hospital · Updated on 2026-02-27
20
Participants Needed
1
Research Sites
148 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research study is an open-label Phase 1 Exploratory/Pilot clinical trial to measure the effects of the incretin mimetic, tirzepatide, on tissue, urine, blood, and microbiome biomarkers associated with colorectal cancer risk and to understand the feasibility of this precision prevention trial approach for a future larger study.
CONDITIONS
Official Title
Pathways, Risk Factors, and mOleculeS to Prevent Early-onset Colorectal Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 50 years
- Body mass index (BMI) between 27 and 40 kg/m2
- Had a screening or surveillance colonoscopy within the past 9 months
- Removal of multiple (at least 2) colon or rectal adenomas, including sessile serrated adenomas but excluding hyperplastic polyps, or a single adenoma 6 mm or larger during the last colonoscopy
- Ability to understand and willing to sign informed consent
You will not qualify if you...
- Ever used incretin mimetic therapies
- History of medullary thyroid cancer or MEN 2 syndrome
- High risk of pancreatitis or contraindicated for tirzepatide use
- History of cancer (excluding non-melanoma skin cancer) within the last 3 years
- History of diabetes mellitus
- History of bowel surgery
- Hereditary cancer syndromes such as HNPCC/Lynch syndrome or familial adenomatous polyposis
- History of inflammatory bowel disease, Crohn's disease, or colitis
- Incomplete or partial polypectomy during prior colonoscopy
- Pregnancy or may become pregnant during the study without contraception counseling
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
A
Andrew T. Chan, MD, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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