Trial NCT07095517
Pathways, Risk Factors, and mOleculeS to Prevent Early-onset Colorectal Tumors
- Phase
- Phase 1
- Sponsor
- Massachusetts General Hospital
- Conditions
- Colorectal Cancer Prevention; Colorectal Adenoma
- Ages
- 18–50 years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
Inclusion Criteria:
* Age 18-50 yearsAge Because no dosing or adverse event data are currently available on the use of tirzepatide in participants <18 years of age, children are excluded from this study. Because we are specifically studying the prevention of EOCRC, which is defined as CRC occurring prior to age 50, the study population will only enroll participants under the age of 50 at baseline.
* BMI between 27 and 40 kg/m2BMI
* Underwent a screening or surveillance colonoscopy within the prior 9 months.
* Removal of multiple (at least 2) colon or rectal adenomas (including sessile serrated adenomas but excluding hyperplastic polyps) or a single adenoma ≥6mm in size during the last colonoscopy
* Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
* Participants who have ever taken incretin mimetic therapies.
* Participants with a history of medullary thyroid cancer or MEN 2 syndrome.
* Participants at high risk of pancreatitis or otherwise contraindicated for use of tirzepatide according to clinical labeling.
* Participants with a history of cancer (excluding non-melanoma skin) within the last three yearsPrior malignancy
* Participants with a history of diabetes mellitusDiabetes
* Participants with a history of bowel surgery
* Participants with hereditary cancer syndromes, including HNPCC/Lynch syndrome or familial adenomatous polyposis
* Participants with a history of inflammatory bowel disease, Crohn's, or colitis.
* Participants with incomplete or partial polypectomy during prior colonoscopy.
* Participants who are pregnant.Pregnancy Participants who may become pregnant or partners of those who may become pregnant while on study will receive contraception counseling. Participants or partners of those who become pregnant while participating on the study should immediately inform their doctor.
Restrictions found (5)
- AgeOutrightinclusion
age <= 50
Show in the text - BMIOutrightinclusion
BMI 27-40 kg/m2
Show in the text - DiabetesOutrightexclusionShow in the text
- PregnancyOutrightexclusionShow in the text
- Prior malignancyOutrightexclusion
within 3 years
Show in the text
Recruiting in Massachusetts
- Massachusetts General Hospital Cancer Center · Boston, Suffolk County