Familial adenomatous polyposis
Conditions
Brief summary
Monitoring of adverse events (AEs) and serious adverse events (SAEs) for the duration of the experimental drug (rapamycin) and up to one month after discontinuation.
Detailed description
Individual analysis of colonoscopies, blinded to patient identity and the timing of colonoscopy in relation to treatment (V1 or V12), enabling descriptive analysis of the number of polyps over 2 mm per segment (rectum, left colon, transverse colon, right colon) and the size of the largest polyp in each segment., Analysis of colonoscopies in a matched manner for each patient (pre-treatment (V1) / post-treatment (V12)) in order to be able to carry out a more specific evaluation of the evolution of polyps after 6 months of rapamycin treatment.
Interventions
Sponsors
Centre Hospitalier Universitaire De Toulouse
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Monitoring of adverse events (AEs) and serious adverse events (SAEs) for the duration of the experimental drug (rapamycin) and up to one month after discontinuation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Individual analysis of colonoscopies, blinded to patient identity and the timing of colonoscopy in relation to treatment (V1 or V12), enabling descriptive analysis of the number of polyps over 2 mm per segment (rectum, left colon, transverse colon, right colon) and the size of the largest polyp in each segment., Analysis of colonoscopies in a matched manner for each patient (pre-treatment (V1) / post-treatment (V12)) in order to be able to carry out a more specific evaluation of the evolution of polyps after 6 months of rapamycin treatment. | — |
Countries
France
Outcome results
None listed