protocolSection identificationModule nctId: NCT06308445, orgStudyIdInfo id: RC31/23/0388, briefTitle: Safety Study for the Use of Rapamycin in Children With Familial Adenomatous Polyposis, acronym: RAPA-4-PAF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-01, primaryCompletionDateStruct date: 2029-08, completionDateStruct date: 2029-08, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: University Hospital, Toulouse, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Familial Adenomatous Polyposis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: Rapamycin, outcomesModule primaryOutcomes measure: Evaluation of the safety profile of two doses of rapamycin in adolescents with Familial Adenomatous Polyposis., secondaryOutcomes measure: Evaluation of the effect of rapamycin on the number of polyps, on the entire colon and by segments (rectum, left colon, transverse colon and right colon) in adolescents suffering from Familial Adenomatous Polyposis, secondaryOutcomes measure: Evaluation of the effect of rapamycin on the size of polyps, on the entire colon and by segments (rectum, left colon, transverse colon and right colon) in adolescents suffering from Familial Adenomatous Polyposis., secondaryOutcomes measure: Evaluation of the effect of rapamycin on the size of the largest polyp in each segment (rectum, left colon, transverse colon and right colon) in adolescents with Familial Adenomatous Polyposis, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: CHU Bordeaux Hôpital Pellegrin, city: Bordeaux, zip: 33076, country: France, contacts name: Raphael Enaud, Dr, role: CONTACT, phone: +33 5 56 79 98 24, email: raphael.enaud@chu-bordeaux.fr, contacts name: Raphaël ENAUD, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.84044, lon: -0.5805, locations facility: CHU Montpellier Hôpital Arnaud de Villeneuve, city: Montpellier, zip: 34295, country: France, contacts name: Laura Kollen, Dr, role: CONTACT, phone: +33 4 67 33 67 33, email: l-kollen@chu-montpellier.fr, contacts name: Laura KOLLEN, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.61092, lon: 3.87723, locations facility: APHP Hôpital Robert Debré, city: Paris, zip: 75019, country: France, contacts name: Jérôme VIALA, Pr, role: CONTACT, phone: +33 1 40 03 36 83, email: jerome.viala@aphp.fr, contacts name: Jérôme VIALA, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.85341, lon: 2.3488, locations facility: CHU Toulouse Hôpital des Enfants, city: Toulouse, zip: 31300, country: France, contacts name: Emmanuel Mas, Pr, role: CONTACT, phone: +33 5 34 55 84 45, email: mas.e@chu-toulouse.fr, contacts name: Emmanuel MAS, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.60426, lon: 1.44367, hasResults: False