Effect of Chemoprevention by Low-dose Aspirin of New or Recurrent Colorectal Adenomas in Patients With Lynch Syndrome
Status:
Recruiting
Trial end date:
2025-12-15
Target enrollment:
Participant gender:
Summary
The proposed trial will evaluate the effect of aspirin 300 mg/d and 100 mg/d during 4 years
vs placebo, in a 4 groups randomised parallel design in Lynch syndrome patients: patients
with proven carriers of pathological mutations in mismatch repairs genes and patients with
personal and family history characterizing Lynch syndrome according to modified Amsterdam
criteria without proven mutation, aged more than 18 years with signed informed consent. The
main hypothesis to be tested is that aspirin could decrease colorectal adenoma recurrence
evaluated during high quality follow-up by colonic chromo-endoscopy in Lynch syndrome
patients. The trial will also explore: (i) colorectal neoplasia recurrence according to
different germline alteration in mismatch repair genes, (ii) observance to chemoprevention in
Lynch syndrome patients, (iii) the burden of adverse events attributable to aspirin in Lynch
syndrome patients, (iv) the dose-effect of aspirin on adenomatous polyp burden. All
pathological samples will be reviewed using a centralized procedure. The INCA regional
network organization and the HNPCC patient organization will allow the recruitment and the
follow-up of a large number of patients with well characterised Lynch syndrome.