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

NCT02813824 | Active Not Recruiting Phase 3

• 1 other identifier: P130937
• Study Type: interventional
• Target: 852
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lynch Syndrome

Outcome Measures

Primary Outcomes (1)

• Number of patients with at least one adenoma seen on chromo-endoscopy 48 months after complete withdrawal of polyps and initiation of treatment (aspirin or placebo)

  To look for a preventive effect of low-dose aspirin (100 or 300 mg/d) compared with placebo on new or recurrent colorectal adenomas in patients with Lynch syndrome

  4 years

Secondary Outcomes (3)

• Delay between the onset of 1 adenoma after complete resection of polyps and date of start of treatment (aspirin vs placebo)

  24 and 48 months

• Number of patients who presented an adenoma during follow-up based on the gene reached (MLH1, MSH2, MSH6, PMS2, or without other identified anomalies)

  24 and 48 months

• Load serrated polyps after 24 and 48 months of treatment

  24 and 48 months

Study Arms (4)

Aspirin300

ACTIVE COMPARATOR

Acetylsalicylic acid 300 mg tablet by mouth, daily dose during 4 years

Drug: Acetylsalicylic acid lysinate 300 mg

Placebo300

PLACEBO COMPARATOR

Placebo (like Acetylsalicylic acid 300 mg) tablet by mouth, daily dose during 4 years

Drug: Placebo (for Aspirin 300)

Aspirin100

ACTIVE COMPARATOR

Acetylsalicylic acid 100 mg tablet by mouth, daily dose during 4 years

Drug: Acetylsalicylic acid lysinate 100 mg

Placebo100

PLACEBO COMPARATOR

Placebo (like Acetylsalicylic acid 100 mg) tablet by mouth, daily dose during 4 years

Drug: Placebo 100 (for Aspirin 100)

Interventions

Acetylsalicylic acid lysinate 300 mg DRUG

Daily dose during 4 years

Also known as: Aspirin300

Aspirin300

Placebo (for Aspirin 300) DRUG

Daily dose during 4 years

Also known as: Placebo300

Placebo300

Acetylsalicylic acid lysinate 100 mg DRUG

Daily dose during 4 years

Also known as: Aspirin100

Aspirin100

Placebo 100 (for Aspirin 100) DRUG

Daily dose during 4 years

Also known as: Placebo100

Placebo100

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Avicenne

Bobigny, 93000, France

Location

Related Publications (1)

• Soualy A, Deutsch D, Benallaoua M, Ait-Omar A, Mary F, Helfen S, Boubaya M, Levy V, Benamouzig R; AAS-Lynch group. Effect of chemoprevention by low-dose aspirin of new or recurrent colorectal adenomas in patients with Lynch syndrome (AAS-Lynch): study protocol for a multicenter, double-blind, placebo-controlled randomized controlled trial. Trials. 2020 Sep 4;21(1):764. doi: 10.1186/s13063-020-04674-8.

  PMID: 32887653 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms, Hereditary Nonpolyposis

Interventions

acetylsalicylic acid lysinate

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Neoplastic Syndromes, Hereditary; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; DNA Repair-Deficiency Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Robert BENAMOUZIG, Pr

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2016
• First Posted: June 27, 2016
• Study Start: November 14, 2017
• Primary Completion: June 15, 2026
• Study Completion (Estimated): December 15, 2027
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)