Colorectal adenomas, Lynch syndrome
Conditions
Brief summary
Number of patients with at least 1adenoma on chromoendoscopy 48months after complete withdrawal of polyps and initiation of IMP. Only neoplastic polyps (progress to cancer), defined by the following histological types as determined by ACP result, will be considered: 1) Adenoma not otherwise specified 2) Tubular adenoma 3) Tubulovillous adenoma 4) Mixed or serrated adenoma (sessile serrated adenoma) 5) Villous adenoma. Additionally, cancers will also be considered for primary endpoint analysis
Detailed description
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, Adenomatous polyp burden, measured by chromoendoscopy as the sum of the size of all adenomatous polyps as a function of the dose of ASA (100 or 300 mg), Load measured by polyps chromoendoscopy as the sum of the size of all polyps according to the aspirin dose (100 or 300mg), Colon cancers diagnosed during the scheduled surveillance colonoscopies, Time to onset of colon cancer diagnosed during the scheduled surveillance colonoscopies, Cancers of the colon interval (diagnosed between 2 surveillance colonoscopies programmed), Time to onset of interval colorectal cancer, Number of colonoscopies performed during follow-up in study, Quality of preparation before colonoscopy, Chromoendoscopy expected execution, Counting of remaining tablets in blisters, Number of events or side effects, Food frequency, Distribution of the bacterial population based on two groups (treated / untreated) and recidivism, Distribution of polymorphisms based on 2 groups (treated / untreated) and recidivism, Proportion of patients with at least one adenoma seen on chromo-endoscopy within 48 months after complete polyp resection and the start of treatment (aspirin vs placebo)
Interventions
DRUGPlacebo of Aspirine 100 mg protect
DRUGplacebo of aspirin 300 mg protect
Sponsors
Assistance Publique Hopitaux De Paris
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with at least 1adenoma on chromoendoscopy 48months after complete withdrawal of polyps and initiation of IMP. Only neoplastic polyps (progress to cancer), defined by the following histological types as determined by ACP result, will be considered: 1) Adenoma not otherwise specified 2) Tubular adenoma 3) Tubulovillous adenoma 4) Mixed or serrated adenoma (sessile serrated adenoma) 5) Villous adenoma. Additionally, cancers will also be considered for primary endpoint analysis | — |
Secondary
| Measure | Time frame |
|---|---|
| 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, Adenomatous polyp burden, measured by chromoendoscopy as the sum of the size of all adenomatous polyps as a function of the dose of ASA (100 or 300 mg), Load measured by polyps chromoendoscopy as the sum of the size of all polyps according to the aspirin dose (100 or 300mg), Colon cancers diagnosed during the scheduled surveillance colonoscopies, Time to onset of colon cancer diagnosed during the scheduled surveillance colonoscopies, Cancers of the colon interval (diagnosed between 2 surveillance colonoscopies programmed), Time to onset of interval colorectal cancer, Number of colonoscopies performed during follow-up in study, Quality of preparation before | — |
Countries
France
Outcome results
None listed