{"doc_desc":{"title":"Cohorte des dysplasies anales de haut grade AIN3","idno":"FRESH-PEF8099-fr","producers":[{"name":"Nathalie GAULT","affiliation":"UNIVERSITE PARIS CITE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF8099-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"8099"},{"agency":"FReSH","code":"FRESH-PEF8099"}]},"title":"Cohorte des dysplasies anales de haut grade AIN3","alternate_title":"AIN3"},"study_authorization":{"agency":[{"name":"CNIL"},{"name":"CESREES"}]},"authoring_entity":[{"type":"investigator","name":"Nathalie;GAULT","PILabo":"APHP.Nord Universit\u00e9 de Paris, H\u00f4pital Bichat Claude Bernard \/ D\u00e9partement Epid\u00e9miologie et Recherche clinique","affiliationName":"UNIVERSITE PARIS CITE","extlink":[{"title":"ORCID","uri":"0000-0002-9913-9760","role":"pi id"},{"title":"IdRef","uri":"147933935","role":"pi id"},{"title":"SIREN","uri":"130025737","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"nathalie.gault@intradef.gouv.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":"LIGUE NATIONALE CONTRE LE CANCER (LNCC)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00rkrv905"},{"title":"SIREN","uri":"775664717"}]},{"name":"MSD FRANCE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00kt5kp12"},{"title":"SIREN","uri":"417890589"}]},{"name":"SANOFI (FRANCE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02n6c9837"},{"title":"SIREN","uri":"395030844"}]},{"name":"SIDACTION (ECS)","extlink":[{"title":"SIREN","uri":"398945543"}]},{"name":"SOCIETE NATIONALE FRAN\u00c7AISE DE GASTRO-ENTEROLOGIE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/04c6sc363"}]},{"name":"","extlink":[]}]},"distribution_statement":{"contact":[{"name":"Laurent;ABRAMOWITZ","email":"laurent.abramowitz@aphp.fr","type":"contact","affiliationName":"UNIVERSITE PARIS CITE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/05f82e368","role":"organisation id","title":"ROR"},{"uri":"130025737","role":"organisation id","title":"SIREN"}]},{"name":"Nathalie;GAULT","email":"nathalie.gault@intradef.gouv.fr","type":"contact","affiliationName":"UNIVERSITE PARIS CITE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/05f82e368","role":"organisation id","title":"ROR"},{"uri":"130025737","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Dysplasie anale de haut grade (AIN3)"},{"keyword":"carcinome \u00e9pidermoide de l'anus"},{"keyword":"facteurs de risque"},{"keyword":"cohorte multicentrique"},{"keyword":"cohorte prospective"}],"topics":[{"topic":"Oncologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/5784b7f1-c7ce-49d9-9f38-aebcda0ff41d"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D008495"}]},{"topic":"Infectiologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/fa2ceeab-3b2f-45e9-9243-e5a8005b98de"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D055552"}]},{"topic":"Gastroent\u00e9rologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/a3898340-a42d-4f5e-a822-1de204a9a867"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D005762"}]},{"topic":"Carcinome in situ d'organes digestifs autres ou non pr\u00e9cis\u00e9s","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1277122723","title":"CIM-11"}]},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"}],"purpose":"L\u2019objectif principal de notre \u00e9tude est d\u2019estimer l\u2019incidence \u00e0 3 ans du cancer \u00e9pidermo\u00efde de l\u2019anus chez les patients ayant une l\u00e9sion anale de type AIN3. Les objectifs secondaires sont : - Estimer l\u2019incidence au-del\u00e0 de 6 ans du cancer \u00e9pidermo\u00efde de l\u2019anus chez les patients ayant une l\u00e9sion anale de type AIN3. - Identifier chez les patients ayant une l\u00e9sion anale de type AIN3, les facteurs de risque (donn\u00e9es d\u00e9mographiques, statut VIH\u2026), les facteurs th\u00e9rapeutiques (type de prise en charge th\u00e9rapeutique), et les facteurs virologiques et immunologiques (g\u00e9notype HPV, pr\u00e9sence ou non des prot\u00e9ines P16 et Ki67) associ\u00e9s \u00e0 l\u2019apparition d\u2019un carcinome \u00e9pidermo\u00efde de l\u2019anus. - Identifier si la pr\u00e9sence des facteurs P16\/Ki67 et des virus HPV \u00e0 haut risque, est associ\u00e9 \u00e0 un sur-risque de r\u00e9cidive des l\u00e9sions AIN3 comme c\u2019est le cas pour les dysplasies de haut grade du col ut\u00e9rin. - Estimer la proportion de patients observants, et identifier les facteurs associ\u00e9s \u00e0 l\u2019observance du suivi (d\u00e9mographiques, statut VIH, type de traitements entrepris\u2026) - Evaluer l\u2019impact de la prise en charge sur la qualit\u00e9 de vie du patient.","abstract":"","coll_dates":[{"start":"2000-01-01","end":"2030-01-01"}],"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\": \"Adulte (19 \u00e0 24 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adulte (25 \u00e0 44 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Adulte (45 \u00e0 64 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        },\n        {\n            \"value\": \"Personne \u00e2g\u00e9e (65 \u00e0 79 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Grand \u00e2ge (80 ans et plus)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"L\u00e9sion anale de type AIN3 diagnostiqu\u00e9e par histologie : - soit a posteriori pour les patients d\u00e9j\u00e0 suivis pour AIN3 compliqu\u00e9 ou non de carcinome \u00e9pidermo\u00efde. Ces patients seront identifi\u00e9s \u00e0 partir des bases de donn\u00e9es des laboratoires d\u2019anatomopathologie depuis le 1er janvier 2000. - soit au moment du diagnostic par le proctologue, pour les patients ayant une premi\u00e8re l\u00e9sion anale dysplasique de type AIN3.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es paracliniques','Donn\u00e9es biologiques','Donn\u00e9es paracliniques (hors biologiques) : Imagerie']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['data management mensuel. Controle des donn\u00e9es manquantes et incoh\u00e9rences. Contr\u00f4le du suivi m\u00e9dian']"}},"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\":\"MeasurementsAndTests.Physical\",\"vocab\":\"CESSDA\"},\"value\":\"Mesures physiques\/biologiques (tension art\u00e9rielle, poids, biochimie, imagerie...)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[500-1000[ individus","response_rate":"900"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Cohorte"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Acc\u00e8s r\u00e9serv\u00e9\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"","conditions":"Contacter le responsable scientifique","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"19-02-2014","lastUpdatedAuto":null,"lastUpdatedManual":"09-09-2020","isContributorPI":"Non","contributorName":"Nathalie GAULT","contributorAffiliation":"UNIVERSITE PARIS CITE","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":["",""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Priv\u00e9 \u00e0 but non lucratif","Industrie","Industrie","Priv\u00e9 \u00e0 but non lucratif","Priv\u00e9 \u00e0 but non lucratif","Priv\u00e9 \u00e0 but non lucratif"],"otherFundingAgentType":["","","","","",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":"Oui"},"collaborations":{"networkConsortium":"Oui"},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Oui","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Donn\u00e9es recueillies de fa\u00e7on r\u00e9trospective puis de fa\u00e7on prospective par le proctologue en charge de l'examen m\u00e9dical et du suivi en consultation.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"44 centres sp\u00e9cialis\u00e9s dans la prise en charge de ces patients en France m\u00e9tropolitaine"},"dataTypes":{"clinicalDataDetails":"d\u00e9mographie, ant\u00e9c\u00e9dents, comportement, sympt\u00f4mes","biologicalDataDetails":"\u00c9l\u00e9ments biologiques :- frottis anal,- biopsie des l\u00e9sions,- analyse cytologique, - analyse histologique, - recherche de prot\u00e9ine P16 et Ki67,- recherche et g\u00e9notypage des virus HPV","isDataInBiobank":"Oui","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}