Using low-dose aspirin to prevent colorectal adenomas in Lynch syndrome patients
Assessment of the Effect of a Daily Chemoprevention by Low-dose Aspirin of New or Recurrent Colorectal Adenomas in Patients With Lynch Syndrome
This study is testing if taking low-dose aspirin can help prevent the return of colon growths in people with Lynch syndrome who are at higher risk for colorectal cancer.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 852 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Bobigny) |
| Trial ID | NCT02813824 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of low-dose aspirin (300 mg and 100 mg daily) compared to a placebo over four years in patients with Lynch syndrome, a genetic condition that increases the risk of colorectal cancer. Participants will be randomly assigned to one of four groups to assess the recurrence of colorectal adenomas through high-quality follow-up using colonic chromo-endoscopy. The study aims to explore various factors, including the impact of different genetic mutations on neoplasia recurrence and the adherence to aspirin treatment. Additionally, it will monitor any adverse effects associated with aspirin use in this high-risk population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with Lynch syndrome, either confirmed by genetic testing or based on family history and modified Amsterdam criteria.
Not a fit: Patients with known allergies to aspirin or those requiring prolonged NSAID treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the recurrence of colorectal adenomas in patients with Lynch syndrome, potentially lowering their risk of developing colorectal cancer.
How similar studies have performed: Previous studies have shown some success with aspirin in reducing colorectal polyp recurrence, but this specific approach in Lynch syndrome patients is being further explored.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bobigny
- Hôpital Avicenne — Bobigny, France (Recruiting)
Study contacts
- Principal investigator: Robert BENAMOUZIG, Pr — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Zahia BEN ABDESSELAM
- Email: zahia.ben-abdesselam@aphp.fr
- Phone: 33148957435
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.