Clinical Trial: Mesalamine for Colorectal Cancer Prevention Program in Lynch Syndrome

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Mesalamine for Colorectal Cancer Prevention Program in Lynch Syndrome - MesaCAPP

Brief Summary: Multicenter, multinational, randomized, 3-arm, double-blind, phase II clinical study with 2400mg Mesalamine, 1200mg Mesalamine or placebo for prevention of neoplasia in Lynch Syndrome patients for 2 years.

Detailed Summary:

This is a multicenter, multinational, randomized, 3-arm, double-blind, phase II clinical study with 2400mg Mesalamine, 1200mg Mesalamine or placebo in LS patients for a 2-year treatment. 540 tumor free carriers of a known genetic mutation in a major MMR gene (including patients in which the polyps are endoscopically removed) will be randomized 1:1:1 (180 each) to receive 2400mg Mesalamine, 1200mg Mesalamine or placebo. Patients will be identified through local or national registries and through collaboration with sites. Tumor free patients, assessed by white light high resolution colonoscopy, will be randomized to the study. A serum and stool sample will be taken to identify for Mesalamine compliance and potential biomarkers. Biopsies of the normal tissue of ascending colon and rectum will be taken at the first and the last colonoscopy.

The aim of the study is to investigate the effect of regular treatment with Mesalamine on the occurrence of colonic neoplasia, tumor multiplicity (the number of detected adenomas/carcinomas) and tumor progression in LS patients.

A 50% reduction of the occurrence of neoplasia in Mesalamine-treated patients is expected. Tumor multiplicity and tumor progression (severity of the neoplastic lesions) will be investigated.


Sponsor: Christoph Gasche

Current Primary Outcome: Reduction in the occurrence of colonic neoplasia in LS patients [ Time Frame: End of study is defined as 24 months +/- 1 month. ]

The primary objective of the study is to test whether mesalamine (low- and high-dose together) reduces the occurrence of colonic benign or malignant neoplasia compared to placebo in LS patients as detected by any colonoscopy until the end of study.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Medical University of Vienna

Dates:
Date Received: February 22, 2017
Date Started: May 2017
Date Completion: May 2024
Last Updated: March 6, 2017
Last Verified: March 2017