{"doc_desc":{"title":"Cohorte des patients surexpos\u00e9s au cours d\u2019une radioth\u00e9rapie de conformation pour un ad\u00e9nocarcinome de la prostate au Centre Hospitalier Jean Monnet d\u2019Epinal","idno":"FRESH-PEF60188-fr","producers":[{"name":"Jean-Marc SIMON","affiliation":"ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE (AP-HM)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60188-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"60188"},{"agency":"FReSH","code":"FRESH-PEF60188"}]},"title":"Cohorte des patients surexpos\u00e9s au cours d\u2019une radioth\u00e9rapie de conformation pour un ad\u00e9nocarcinome de la prostate au Centre Hospitalier Jean Monnet d\u2019Epinal","alternate_title":"EPOPA"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Jean-Marc;SIMON","PILabo":"SERVICE D\u2019ONCOLOGIE RADIOTH\u00c9RAPIQUE GROUPE HOSPITALIER PITI\u00c9-SALP\u00caTRI\u00c8RE 47-83 BOULEVARD DE L\u2019H\u00d4PITAL, 75651 PARIS CEDEX 13 AP-HP","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"14921748X","role":"pi id"},{"title":"SIREN","uri":"267500452","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"jean-marc.simon@aphp.fr","isContact":"Oui"},{"type":"investigator","name":"Tabassome;SIMON","PILabo":"UNIT\u00c9 DE RECHERCHE CLINIQUE DE L\u2019EST PARISIEN SERVICE DE PHARMACOLOGIE FACULT\u00c9 DE M\u00c9DECINE PIERRE ET MARIE CURIE UNIT\u00c9 DE RECHERCHE CLINIQUE DE L\u2019EST PARISIEN SERVICE DE PHARMACOLOGIE FACULT\u00c9 DE M\u00c9DECINE PIERRE ET MARIE CURIE","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"ORCID","uri":"0000-0002-4550-0450","role":"pi id"},{"title":"IdRef","uri":"070443122","role":"pi id"},{"title":"SIREN","uri":"267500452","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"tabassome.simon@aphp.fr","isContact":"Oui"},{"type":"investigator","name":"Patrick;GOURMELON","PILabo":"INSTITUT DE RADIOPROTECTION ET DE S\u00dbRET\u00c9 NUCL\u00c9AIRE (IRSN) DIRECTION DE LA RADIOPROTECTION DE L\u2019HOMME IRSN","affiliationName":"AUTORITE DE SURETE NUCLEAIRE ET DE RADIOPROTECTION (ASNR)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"095687068","role":"pi id"},{"title":"SIREN","uri":"130001803","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"patrick.gourmelon@irsn.fr","isContact":"Oui"}],"oth_id":[{"name":""}],"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":"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-Marc;SIMON","email":"jean-marc.simon@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"}]},{"name":"Tabassome;SIMON","email":"tabassome.simon@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"}]},{"name":"Patrick;GOURMELON","email":"patrick.gourmelon@irsn.fr","type":"contact","affiliationName":"AUTORITE DE SURETE NUCLEAIRE ET DE RADIOPROTECTION (ASNR)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/04dbtaf18","role":"organisation id","title":"ROR"},{"uri":"130001803","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"surexposition"},{"keyword":"doses re\u00e7ues"},{"keyword":"tissus sains irradi\u00e9s"},{"keyword":"complicationsdonn\u00e9es biologiques"},{"keyword":"ph\u00e9notypiques"},{"keyword":"g\u00e9n\u00e9tiques"},{"keyword":"s\u00e9quelles"},{"keyword":"incidence"}],"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":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques : Emploi","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques","vocab":"health determinant"}],"purpose":"Corr\u00e9ler, dans cette cohorte de patients ayant subi une surexposition \u00e0 des degr\u00e9s divers, les doses re\u00e7ues, les volumes de tissus sains irradi\u00e9s, et les complications observ\u00e9es aux donn\u00e9es biologiques, ph\u00e9notypiques et g\u00e9n\u00e9tiques. L\u2019incidence et la gravit\u00e9 des s\u00e9quelles et des complications iatrog\u00e8nes de la radioth\u00e9rapie (selon les \u00e9chelles soma-lent et CTCAE) seront corr\u00e9l\u00e9es \u00e0 la reconstitution pr\u00e9cise de la dosim\u00e9trie de l\u2019irradiation r\u00e9ellement re\u00e7ue par chaque patient (cumul de la dose de radioth\u00e9rapie prescrite et de celle d\u00e9livr\u00e9e par les contr\u00f4les quotidiens), \u00e0 partir des donn\u00e9es du dossier technique, et du syst\u00e8me de planification du traitement. Objectif secondaire : Recueillir des collections biologiques \u00e0 partir de pr\u00e9l\u00e8vements sanguins (s\u00e9roth\u00e8que, dnath\u00e8que, lymphocytes) afin de pouvoir corr\u00e9ler les doses de radioth\u00e9rapie re\u00e7ues par les tissus sains et les complications iatrog\u00e8nes observ\u00e9es aux donn\u00e9es biologiques, ph\u00e9notypiques et g\u00e9n\u00e9tiques. ces collections permettront : - de rechercher les facteurs associ\u00e9s \u00e0 une susceptibilit\u00e9 de d\u00e9velopper des complications radio-induites par les tissus sains ; - d\u2019\u00e9tudier la biologie de la fibrose radique ; - d\u2019\u00e9tudier la radiosensibilit\u00e9 des tissus sains : paroi rectale ; - d\u2019\u00e9tudier la relation dose-effet sur le contr\u00f4le biologique de l\u2019ad\u00e9nocarcinome de la prostate ; - de mettre en place des protocoles th\u00e9rapeutiques des fibroses radiques.","abstract":"","coll_dates":[{"start":"2008-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Grand Est']","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\": \"Patients ayant \u00e9t\u00e9 trait\u00e9s pour un cancer de prostate dans le service de radioth\u00e9rapie du centre hospitalier Jean Monnet entre 2000 et 2006.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l&#x27;\u00e9tude','Donn\u00e9es biologiques']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['- Pr\u00e9sence d\\'une requ\u00eate de coh\u00e9rence au moment de la saisie des donn\u00e9es informatiques et apr\u00e8s la saisie des donn\u00e9es informatiques.- Gestion des donn\u00e9es manquantes : retour au dossier source et\/ou par retour vers le patient. - 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"}]},"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\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"< 500 individus","response_rate":"120 sujets inclus avec recueil sanguin \/ 120 with blood sample selection409 patients concern\u00e9s, dont 29 sont d\u00e9c\u00e9d\u00e9s \/ 409 concerned with 29 deaths"},"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":"Utilisation des donn\u00e9es par des \u00e9quipes acad\u00e9miques \u00e0 d\u00e9terminer. Utilisation impossible des donn\u00e9es par des industriels.","conditions":"","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":"08-03-2013","lastUpdatedAuto":null,"lastUpdatedManual":"06-09-2020","isContributorPI":"Non","contributorName":"Jean-Marc SIMON","contributorAffiliation":"ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE (AP-HM)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"List of publications in HAL","link":"http:\/\/tinyurl.com\/HAL-EPOPA"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"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":"Entretiens : saisie manuelle \u00e0 partir d\u2019un questionnaire papierExamens cliniques : saisie manuscrite","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"Centre hospitalier d'Epinal, d\u00e9partement des Vosges"},"dataTypes":{"clinicalDataDetails":"Examen clinique \u00e0 l\u2019inclusion et au cours du suivi (tous les 2 ans) : toucher rectal pour suivre l'\u00e9volution du cancer de la prostate, et de l'\u00e9ventuelle rectite radique","biologicalDataDetails":"Pr\u00e9l\u00e8vements sanguins","isDataInBiobank":"Oui","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}