Colorectal adenoma Trials in Disease

Study on the Effect of Low-Dose Aspirin in Preventing New or Recurrent Colorectal Polyps in Patients with Lynch Syndrome

This trial is examining whether taking a low daily dose of aspirin can help prevent the formation of new colorectal adenomas or stop existing ones from returning in patients with Lynch syndrome. Lynch syndrome is an inherited condition that significantly raises the risk of developing colorectal cancer and other cancers, often at a younger age than typical.

Who can participate: This study is looking for men and women with Lynch syndrome who have mutations in specific genes called "mismatch repair" genes, or who have a personal or family history meeting certain criteria for Lynch syndrome. Participants must be older than 25 years (or older than 18 if there's an early family history requiring frequent colonoscopies). They must be younger than 75 years and must have had a colonoscopy within the past 180 days with all removable polyps removed. Participants must agree not to use aspirin regularly during the study outside of the trial protocol. Women who can become pregnant must use effective contraception methods. Participants must be covered by French Social Security and must sign an informed consent form.

Who cannot participate: The trial excludes patients who do not have Lynch syndrome or do not have colorectal adenomas. Those who fall outside the specified age range or who are considered part of a vulnerable population requiring special protection in clinical trials are also excluded.

What the trial involves: Participants will be randomly assigned to receive either low-dose aspirin (either 100 mg or 300 mg daily) or a placebo. The medication comes in the form of a gastro-resistant tablet, which is designed to dissolve in the intestines rather than the stomach to reduce irritation. The treatment period lasts 48 months. During this time, participants will have regular follow-up visits including scheduled colonoscopies and chromoendoscopy procedures to check for any new adenomas. The study will track how many participants develop at least one adenoma after the 48-month treatment period, how long it takes for adenomas to appear, and the overall number and burden of polyps. Safety monitoring will occur throughout the trial.

Investigational drug: The trial is testing aspirin, a non-steroidal anti-inflammatory drug (NSAID). Aspirin works by inhibiting enzymes called cyclooxygenases, which are involved in inflammation and cell growth. The researchers are investigating whether aspirin's anti-inflammatory properties can help prevent the development of colorectal adenomas in people with Lynch syndrome, potentially reducing their risk of progressing to colorectal cancer.