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Clinical Trials in France / NCT02813824
Active, not recruiting Phase 3

Effect of Chemoprevention by Low-dose Aspirin of New or Recurrent Colorectal Adenomas in Patients With Lynch Syndrome

NCT02813824 · tracked via the Priya Life Science France tracker
Sponsor
Assistance Publique - Hôpitaux de Paris
Phase
Phase 3
Started
2017-11-14
Last updated
2025-07-08

Condition(s) studied

Lynch Syndrome

Investigational drug(s) / intervention(s)

Acetylsalicylic acid lysinate 300 mgPlacebo (for Aspirin 300)Acetylsalicylic acid lysinate 100 mgPlacebo 100 (for Aspirin 100)

Acetylsalicylic acid lysinate 300 mg: Daily dose during 4 years

Placebo (for Aspirin 300): Daily dose during 4 years

Acetylsalicylic acid lysinate 100 mg: Daily dose during 4 years

Placebo 100 (for Aspirin 100): Daily dose during 4 years

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Patient with Lynch syndrome bearing an alteration of "mismatch repair" genes or,when no characteristic alteration has been found, with a personal or family history of Lynch syndrome according to modified Amsterdam criteria * Aged more than 25 years, et aged more than 18 years with an early familial history and any reason to perform a colonoscopy every 2 years * Aged less than 75 years Exclusion Criteria: * Known allergy to aspirin (including a history of asthma induced by the administration of salicylates or substances with similar activity, including non-steroidal anti-inflammatory) * Need for a prolonged treatment (prevention of cardio-vascular risk) or repeated treatments (recurring migraines) using aspirin or another non-steroidal anti-inflammatory drug (NSAID) * Pregnancy or breast feeding * Participation to another clinical trial during the 12 weeks before inclusion

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Hôpital Avicenne Bobigny France

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Other trials for the same condition

Study Aiming to Test Whether Non-invasive Liquid Biopsies Can Safely Reduce Invasive Surveillance Methods in Lynch Syndrome Starting soon
CAD-EYE System for the Detection of Neoplastic Lesions in Patients With Lynch Syndrome Recruiting
Small Bowel Capsule Endoscopy in Lynch Syndrome Recruiting
Impact of Consumption of Ultra-processed Foods in Individuals at High Risk of Cancer Recruiting
Determining the Prevalence of Muir-Torre Syndrome in Patients With Lynch Syndrome Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02813824 on ClinicalTrials.gov ↗ ← All trials in France