Table 3 Trial registration data set
Data category | Information |
|---|---|
Primary registry and trial identifying number | ClinicalTrials.gov NCT02813824 |
Date of registration in primary registry | June 27, 2016 |
Other study ID numbers | P130937 |
Source(s) of monetary or material support | Programme Hospitalier de Recherche Clinique National (P130937) La Fondation ARC Bayer Laboratory |
Primary sponsor | Programme Hospitalier de Recherche Clinique National (P130937) |
Secondary sponsor(s) | La Fondation ARC Bayer Laboratory (investigational product) |
Contact for public queries | Amal BOURKEB amal.bourkeb@aphp.fr |
Contact for scientific queries | Pr Robert BENAMOUZIG robert.benamouzig@aphp.fr |
Official title | Assessment of the Effect of a Daily Chemoprevention by Low-dose Aspirin of New or Recurrent Colorectal Adenomas in Patients With Lynch Syndrome |
Countries of recruitment | France |
Health condition(s) or problem(s) studied | Lynch syndrome |
Intervention(s) | Aspirin low dose (100 or 300 mg) versus placebo in lynch syndrome patients |
Key inclusion and exclusion criteria | Ages eligible for study: ≥ 18 years Sexes eligible for study: both Accepts healthy volunteers: no Inclusion criteria: Lynch syndrome patients aged over 25 or 18 years of age in cases with an early family history, with an indication for colonoscopic surveillance every 2 years, under 75 years old, performing a colonoscopy within 180 days before inclusion, with removal of all endoscopically resectable polyps, no regularly use of aspirin… Exclusion criteria: Total colectomy, adenomatous polyposis associated with known alteration of APC gene or MYH gene, allergy to aspirin, allergy known to indigo carmine used for chromoendoscopy, indication of prolonged treatment or repeated treatment with aspirin or other nonsteroidal anti-inflammatory drug, abnormality of hemostasis or coagulation… |
Study type | Interventional Allocation: randomized Parallel assignment Masking: Quadruple (participant, care provider, investigator, outcomes assessor) Primary purpose: Prevention Phase III |
Date of first enrolment | November 14, 2017 |
Estimated primary completion date | December 2024 |
Estimated study completion date | December 2025 |
Protocol version number and date | Version 3-0; June 2, 2017 |
Target sample size | 852 participants |
Recruitment status | Recruiting |
Primary outcome(s) | 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) [time frame: 4 years] |
Key secondary outcomes | Delay between the onset of 1 adenoma after complete resection of polyps and date of start of treatment (aspirin vs placebo) Number of patients who presented an adenoma during follow-up based on the gene reached (MLH1, MSH2, MSH6, PMS2, or without other identified anomalies) Load serrated polyps after 24 and 48 months of treatment |