{"doc_desc":{"title":"Cohorte de patients trait\u00e9s par l'hormone de croissance recombinante dans l'enfance","idno":"FRESH-PEF60178-fr","producers":[{"name":"Jean-Claude CAREL","affiliation":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60178-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"60178"},{"agency":"FReSH","code":"FRESH-PEF60178"}]},"title":"Cohorte de patients trait\u00e9s par l'hormone de croissance recombinante dans l'enfance","alternate_title":"SAGHE : Sant\u00e9 Adulte GH Enfant"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Jean-Claude;CAREL","PILabo":"CENTRE DE REFERENCE MALADIES ENDOCRINIENNES RARES DE LA CROISSANCE MINISTERE DE LA SANT\u00c9. AP-HP","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"ORCID","uri":"0000-0002-0424-6767","role":"pi id"},{"title":"IdRef","uri":"057023034","role":"pi id"},{"title":"SIREN","uri":"267500452","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"jean-claude.carel@aphp.fr","isContact":"Oui"}],"oth_id":[{"name":"","type":""},{"name":"","type":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00pg5jh14","role":"sponsor id"},{"title":"SIREN","uri":"267500452","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"EUROPEAN COMMISSION RESEARCH","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00k4n6c32"}]},{"name":"AGENCE NATIONALE DE SECURITE DU MEDICAMENT ET DES PRODUITS DE SANTE (ANSM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01g80gk13"},{"title":"SIREN","uri":"180036113"}]},{"name":"INSTITUT NATIONAL DU CANCER (INCA)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/03m8vkq32"},{"title":"SIREN","uri":"187512777"}]},{"name":"MINISTERE DU TRAVAIL, DE LA SANTE, DES SOLIDARITES ET DES FAMILLES","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01wp0c315"},{"title":"SIREN","uri":"130016546"}]}]},"distribution_statement":{"contact":[{"name":"Jean-Claude;CAREL","email":"jean-claude.carel@aphp.fr","type":"contact","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/00pg5jh14","role":"organisation id","title":"ROR"},{"uri":"267500452","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Insertion socio-professionnelle"},{"keyword":"insuffisance somatotrope"},{"keyword":"le syndrome de Turner"},{"keyword":"hormone de croissance"},{"keyword":"manifestations hormonales"},{"keyword":"osseuses"},{"keyword":"et cardiovasculaires"},{"keyword":"particularit\u00e9s ph\u00e9notypiques et\/ou g\u00e9n\u00e9tiques"},{"keyword":"\u00e9ducation"},{"keyword":"professionnelle"},{"keyword":"m\u00e9taboliques"},{"keyword":"d\u00e9terminants"},{"keyword":"insertion sociale"},{"keyword":"impact psychologique"},{"keyword":"prise en charge"},{"keyword":"efficacit\u00e9"},{"keyword":"risque tumoral"}],"topics":[{"topic":"Endocrinologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/d1dd1bac-5313-4ab3-837f-4acd3ec521a7"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D004704"}]},{"topic":"P\u00e9diatrie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/bf8aaaac-ddee-41cd-bb8a-c5a63de3fcbd"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D010372"}]},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques : Emploi","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"}],"purpose":"R\u00e9pondre aux questions non r\u00e9solues concernant l'insuffisance somatotrope, le syndrome de Turner et patients traites par hormone de croissance. Objectifs secondaires : - Pr\u00e9ciser la fr\u00e9quence et la gravit\u00e9 des manifestations hormonales, m\u00e9taboliques, osseuses, et cardiovasculaires de la maladie tout au long de la vie, ainsi que leurs d\u00e9terminants. - Identifier des sous groupes de patients selon la s\u00e9v\u00e9rit\u00e9 et leurs particularit\u00e9s ph\u00e9notypiques et\/ou g\u00e9n\u00e9tiques en lien avec les deux laboratoires fran\u00e7ais de g\u00e9n\u00e9tique mol\u00e9culaire, hospitaliers et Inserm des anomalies de d\u00e9veloppement de l\u2019hypophyse. - Mieux conna\u00eetre le devenir des patients en termes d\u2019\u00e9ducation, d\u2019insertion sociale, professionnelle et d\u2019impact psychologique. - Am\u00e9liorer les strat\u00e9gies de prise en charge appropri\u00e9es pendant l\u2019enfance, la p\u00e9riode de transition et chez l\u2019adulte. - R\u00e9\u00e9valuer l\u2019efficacit\u00e9 \u00e0 long terme du traitement par hormone de croissance, traitement de r\u00e9f\u00e9rence de l\u2019insuffisance somatotrope. certaines questions restent en suspend, outre le co\u00fbt \u00e9lev\u00e9, l\u2019efficacit\u00e9 sur la taille finale de m\u00eame que sur la qualit\u00e9 de vie chez un nombre important de patients. - Surveiller la tol\u00e9rance \u00e0 long terme et en particulier le risque tumoral.","abstract":"","coll_dates":[{"start":"1985-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individus","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Masculin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"F\u00e9minin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D005260\"\n            }\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"value\": \"Nouveau-n\u00e9 (naissance \u00e0 28j)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D007231\"\n            }\n        },\n        {\n            \"value\": \"Enfance (6 \u00e0 12 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002648\"\n            }\n        },\n        {\n            \"value\": \"Adolescence (13 \u00e0 18 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000293\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Traitement par l'hormone de croissance recombinante dans l'enfance de 1985 \u00e0 1997.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude','Donn\u00e9es paracliniques','Donn\u00e9es paracliniques (hors biologiques) : Imagerie']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Pr\u00e9sence d\\'une requ\u00eate de coh\u00e9rence apr\u00e8s la saisie des donn\u00e9es informatiques.Gestion des donn\u00e9es manquantes par retour au dossier source et\/ou par retour vers le patient ou un tiers.Relance des m\u00e9decins pour r\u00e9aliser les visites de suivi.Relance des sujets pour r\u00e9aliser les visites de suivi.Les patients sont inform\u00e9s de l\\'utilisation de leur donn\u00e9es par \u00e9crit.']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/morbidit\u00e9\r\nEv\u00e9nements de sant\u00e9\/mortalit\u00e9\r\nConsommation de soins\/services de sant\u00e9\r\nQualit\u00e9 de vie\/sant\u00e9 per\u00e7ue"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via des structures (services ou \u00e9tablissements de sant\u00e9, \u00e9coles, entreprises\u2026)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Questionnaire auto-administr\u00e9\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[10000-20000[ individus","response_rate":"10 489"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study 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