Safety Study for the Use of Rapamycin in Children With Familial Adenomatous Polyposis

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12-17
SponsorUniversity Hospital, Toulouse

About this trial

The hypothesize of this research is that rapamycin is effective and well-tolerated in teenagers with familial adenomatous polyposis (FAP). Rapamycin could be effective in blocking the formation of adenomas and/or their evolution by decreasing their size and number. Researchers aim to assess the safety profile of rapamycin in FAP adolescents using a 2 low dose regimen.

Eligibility criteria

Qualifiers

Children aged 12 to 17 at time of inclusion.

Patients with colonoscopy for diagnosis or follow-up of FAP.

≥ 5 polyps (> 2 mm) at initial colonoscopy (V1).

Free and informed consent, signed by both holders of parental authority/legal representative, with the accord of the minor patient.

Disqualifiers

Inability to understand the nature and goals of the study and/or communication difficulties observed by the investigator.

Contraindication to performing a colonoscopy.

< 5 polyps (>2 mm) registered during initial colonoscopy (V1).

Advanced disease with high-grade dysplasia adenoma or even adenocarcinoma in situ that should required colectomy

Trial design

Treatments tested in this trial

  • Rapamycin

Treatment groups

25 Participants
are divided into 1 treatment group

Sponsors and collaborators