[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100539792":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":23,"locations":31,"responsibleParty":97,"collaborators":11,"id":99,"slug":100,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":101,"sex":107,"minAge":108,"maxAge":109,"enrollmentInfo":110,"targetDuration":11,"studyType":113,"phases":114,"briefSummary":116,"conditions":117,"keywords":119,"overallStatus":124,"whyStopped":11,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"University Hospital, Toulouse","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Rapamycin","EXPERIMENTAL",null,[13],"Drug: Rapamycin",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":11},"DRUG","This is a 2-dose rapamycin safety study, with a target through level of 3 to \\\u003C5 ng\u002Fml for the first 3 months and 5-8 ng\u002Fml for the next 3 months for each of the included patients. To avoid the possible cumulative effect, the two treatment phases will be separated by a 3-weeks wash-out period.",[9],[20],{"name":21,"affiliation":5,"role":22},"Emmanuel Mas, Pr","STUDY_CHAIR",[24,28],{"name":21,"role":25,"phone":26,"phoneExt":11,"email":27},"CONTACT","+33 5 34 55 84 45","mas.e@chu-toulouse.fr",{"name":29,"role":25,"phone":11,"phoneExt":11,"email":30},"Isabelle KIEFFER, CRA","kieffer.i@chu-toulouse.fr",[32,52,68,84],{"facility":33,"status":11,"city":34,"state":11,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"CHU Bordeaux Hôpital Pellegrin","Bordeaux","33076","France","FR",{"type":39,"coordinates":40},"Point",[41,42],-0.58046,44.84124,{"lat":42,"lon":41},[45,49],{"name":46,"role":25,"phone":47,"phoneExt":11,"email":48},"Raphael Enaud, Dr","+33 5 56 79 98 24","raphael.enaud@chu-bordeaux.fr",{"name":50,"role":51,"phone":11,"phoneExt":11,"email":11},"Raphaël ENAUD, MD","PRINCIPAL_INVESTIGATOR",{"facility":53,"status":11,"city":54,"state":11,"zip":55,"country":36,"countryCode":37,"cosmosGeoPoint":56,"geoPoint":60,"contacts":61},"CHU Montpellier Hôpital Arnaud de Villeneuve","Montpellier","34295",{"type":39,"coordinates":57},[58,59],3.87635,43.61093,{"lat":59,"lon":58},[62,66],{"name":63,"role":25,"phone":64,"phoneExt":11,"email":65},"Laura Kollen, Dr","+33 4 67 33 67 33","l-kollen@chu-montpellier.fr",{"name":67,"role":51,"phone":11,"phoneExt":11,"email":11},"Laura KOLLEN, MD",{"facility":69,"status":11,"city":70,"state":11,"zip":71,"country":36,"countryCode":37,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"APHP Hôpital Robert Debré","Paris","75019",{"type":39,"coordinates":73},[74,75],2.3488,48.85341,{"lat":75,"lon":74},[78,82],{"name":79,"role":25,"phone":80,"phoneExt":11,"email":81},"Jérôme VIALA, Pr","+33 1 40 03 36 83","jerome.viala@aphp.fr",{"name":83,"role":51,"phone":11,"phoneExt":11,"email":11},"Jérôme VIALA",{"facility":85,"status":11,"city":86,"state":11,"zip":87,"country":36,"countryCode":37,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"CHU Toulouse Hôpital des Enfants","Toulouse","31300",{"type":39,"coordinates":89},[90,91],1.44367,43.60426,{"lat":91,"lon":90},[94,95],{"name":21,"role":25,"phone":26,"phoneExt":11,"email":27},{"name":96,"role":51,"phone":11,"phoneExt":11,"email":11},"Emmanuel MAS, MD",{"type":98,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100539792","phase-2-safety-study-for-the-use-of-rapamycin-in-children-with-familial-adenomatous-polyposis-100539792",false,"NCT06308445","Safety Study for the Use of Rapamycin in Children With Familial Adenomatous Polyposis","Safety Study for the Use of Rapamycin in Children With Familial Adenomatous Polyposis.","RAPA-4-PAF","Inclusion Criteria:\n\n* Children aged 12 to 17 at time of inclusion.\n* Patients with colonoscopy for diagnosis or follow-up of FAP.\n* ≥ 5 polyps (\\> 2 mm) at initial colonoscopy (V1).\n* Free and informed consent, signed by both holders of parental authority\u002Flegal representative, with the accord of the minor patient.\n* Affiliated with a social security scheme.\n* Patients of childbearing potential must agree to the use of a method of contraception during the study.\n\nExclusion Criteria:\n\n* Inability to understand the nature and goals of the study and\u002For communication difficulties observed by the investigator.\n* Contraindication to performing a colonoscopy.\n* \\\u003C 5 polyps (\\>2 mm) registered during initial colonoscopy (V1).\n* Advanced disease with high-grade dysplasia adenoma or even adenocarcinoma in situ that should required colectomy\n* Signs of primary tuberculosis infection or respiratory infection\n* Any other medical or psychological condition deemed incompatible with the proper conduct of the study according to the investigator.\n* Contraindications to rapamycin use\n* Participation in other biomedical research\n* Deprivation of liberty of the legal guardians by judicial or administrative decision.\n* Pregnancy, breastfeeding","ALL","12 Years","17 Years",{"count":111,"type":112},25,"ESTIMATED","INTERVENTIONAL",[115],"PHASE2","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\u002For 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.",[118],"Familial Adenomatous Polyposis",[120,121,122,123],"Safety use","rapamycin","prophylaxis","teenager","NOT_YET_RECRUITING","2026-05-04",{"date":127,"type":128},"2026-05-08","ACTUAL",{"date":130,"type":112},"2026-09-01",{"date":132,"type":112},"2030-09",{"name":5,"class":6},4]