Actively Recruiting
Led by Ann-Sofie Backman · Updated on 2024-12-17
150
Participants Needed
8
Research Sites
678 weeks
Total Duration
A
Ann-Sofie Backman
Lead Sponsor
T
The Swedish Research Council
Collaborating Sponsor
Researchers are investigating the use of mesalamine (5-ASA) to prevent colorectal neoplasia in patients with Lynch Syndrome, a genetic condition linked to higher colorectal cancer risk. This multicenter, multinational, randomized, double-blind phase II clinical trial aims to study the effect of daily mesalamine intake over two years compared to a placebo. The focus is on the occurrence, number, and progression of colorectal tumors in tumor-free patients with mutations in major mismatch repair genes. Participants will be randomly assigned to one of two groups: one receiving 2000 mg of mesalamine once daily for two years, and the other receiving a placebo with the same schedule. The investigational products are supplied as sachets with slow-releasing granules. Tumor-free status is confirmed by high-resolution colonoscopy, and biopsies of normal colon tissue will be taken at the start and end of the study treatment. Blood and stool samples will be collected to analyze microbiota, circulating tumor DNA, and other biomarkers. During the study, participants will undergo colonoscopies and provide biological samples for monitoring. Researchers will assess colorectal neoplasia occurrence, tumor multiplicity, and tumor progression at 24 months and again at six years. Safety and adverse events will be closely monitored. The study will last for over two years of treatment with follow-up assessments extending to six years, ensuring thorough long-term observation of treatment effects and participant health.
CONDITIONS
Mesalamine for Colorectal Cancer Prevention Program in Lynch Syndrome
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 years
Participants receive either 2000mg mesalamine or placebo once daily as part of the study treatment.
Regular visits for medication dispensing and monitoring during the 2-year treatment period
Duration - Up to 4 years after treatment completion
Participants are monitored for colorectal neoplasia occurrence, tumor multiplicity, and tumor progression after treatment ends.
Periodic visits for assessments up to year 6 of the study
Total: 8 locations
1
Aalborg University Hospital
Aalborg, Denmark, 9000
Not Yet Recruiting
2
Hvidovre Hospital
Hvidovre, Denmark, 2650
Actively Recruiting
3
Sahlgrenska University Hsospital
Gothenburg, Gothenburg, Sweden, 416 85
Actively Recruiting
4
Skåne University Hospital
Malmö, Skåne County, Sweden, 205 02
Actively Recruiting
5
Ersta Hospital/Ersta Diakoni
Stockholm, Sweden, 116 91
Actively Recruiting
6
Karolinska University Hospital
Stockholm, Sweden, 171 76
Active, Not Recruiting
7
Norrland University Hospital
Umeå, Sweden, 901 85
Actively Recruiting
8
Akademiska hospital
Uppsala, Sweden, 751 85
Not Yet Recruiting
A
Ann-Sofie Backman, MD PhD
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Ann-Sofie Backman, Alexander Frank, Lars Joachim Lindberg...
https://pubmed.ncbi.nlm.nih.gov/41213710