RecruitingPhase 2NCT04920149

Mesalamine for Colorectal Cancer Prevention Program in Lynch Syndrome


Sponsor

Ann-Sofie Backman

Enrollment

150 participants

Start Date

Mar 21, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Multicenter, multinational, randomized, 2-arm, double-blind, phase II clinical study with 2000mg mesalamine, or placebo for prevention of colorectal neoplasia in Lynch Syndrome patients during and following daily intake for 2 years.


Eligibility

Min Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether mesalamine (an anti-inflammatory drug commonly used for inflammatory bowel disease) can prevent colorectal cancer in people with Lynch syndrome — an inherited condition that significantly raises the risk of developing colon cancer. **You may be eligible if:** - You carry a confirmed genetic mutation in MLH1, MSH2, or MSH6 that causes Lynch syndrome - You are 30 or older and currently cancer-free (or have had polyps removed) - You are using effective contraception or are post-menopausal (if female) **You may NOT be eligible if:** - You carry a PMS2 gene mutation (a different Lynch syndrome variant) - You have had stage 3 or 4 colorectal cancer - You regularly take aspirin, NSAIDs, or COX-2 inhibitors - You have had a colectomy (surgical removal of the colon) - You are allergic to 5-ASA (mesalamine) - Your kidney or liver function is severely impaired - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMesalamine

The IMP will be supplied as sachets with slow-releasing granules.

DRUGPlacebo

The IMP will be supplied as sachets with slow-releasing granules.


Locations(8)

Aalborg University Hospital

Aalborg, Denmark

Hvidovre Hospital

Hvidovre, Denmark

Sahlgrenska University Hsospital

Gothenburg, Gothenburg, Sweden

Skåne University Hospital

Malmö, Skåne County, Sweden

Ersta Hospital/Ersta Diakoni

Stockholm, Sweden

Karolinska University Hospital

Stockholm, Sweden

Norrland University Hospital

Umeå, Sweden

Akademiska hospital

Uppsala, Sweden

View Full Details on ClinicalTrials.gov

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NCT04920149


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