Health TrialsbyHealthPanel

Pathways, Risk Factors, and mOleculeS to Prevent Early-onset Colorectal Tumors

ConditionsColorectal Cancer PreventionColorectal Adenoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-50
SponsorMassachusetts General Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-50 years 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/m2

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

Disqualifiers

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 years

Trial design

Design model

Single group

Treatments tested in this trial

  • Tirzepatide

    Drug

    Study drug injected subcutaneously once a week

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: TirzepatideExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Urinary PGE-M

To determine the effect of tirzepatide intervention on urinary prostaglandin metabolites (PGE-M), an established CRC risk biomarker, in context of changes in body weight.

Time frame
From enrollment to the end of treatment at 24 weeks

Secondary outcomes

1

Change in Plasma GDF-15

Comparing change in GDF-15 in pre- and post-treatment plasma

Time frame
From enrollment to the end of treatment at 24 weeks

Other outcomes

1

Change in Microbiome

Comparing change in gut microbiome features (species - to strain level specificity; metabolic pathways; enzymes) and metabolites using deep meta'omic profiling in pre- and post- treatment samples.

Time frame
From enrollment to the end of treatment at 24 weeks
2

Change in ISC Marker Gene Expression

Assess the difference in the change of ISC marker using scRNA-seq data anlysis

Time frame
From enrollment to the end of treatment at 24 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Cancer Research UK

Collaborator

Source ClinicalTrials.gov
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