{"doc_desc":{"title":"Cohort of patients overexposed during a course of conformal radiotherapy for a prostate adenocarcinoma in Jean Monnet Hospital in Epinal","idno":"FRESH-PEF60188-en","producers":[{"name":"Jean-Marc SIMON","affiliation":"ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE (AP-HM)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60188-en","IDno":{"metadata_no":[{"agency":"PEF","code":"60188"},{"agency":"FReSH","code":"FRESH-PEF60188"}]},"title":"Cohort of patients overexposed during a course of conformal radiotherapy for a prostate adenocarcinoma in Jean Monnet Hospital in Epinal","alternate_title":"EPOPA"},"study_authorization":{"agency":[]},"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":"Yes"},{"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":"Yes"},{"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":"Yes"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (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":"doses"},{"keyword":"irradiated tissues"},{"keyword":"overexposure"},{"keyword":"complications"},{"keyword":"iatrogenic effects"},{"keyword":"dosimetry"}],"topics":[{"topic":"Oncology","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":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Socio-demographic and economic determinants: Employment","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"},{"topic":"Socio-demographic and economic determinants","vocab":"health determinant"}],"purpose":"To correlate received doses and volume of irradiated normal tissues in the cohort of patients who underwent overexposure of varying degrees, as well as complications observed with biologic, phenotypic and genetic data. The incidence and severity of iatrogenic effects and sequelae of radiotherapy (according to soma-lent and CTCAE scales) are correlated using a precise reconstruction of actual irradiation dosimetry received by each patient (total radiation dose prescribed and issued by daily controls) according to technical dossier data and system treatment planning. Secondary objective: to gather biological collections from blood samples (serum bank, DNA bank, lymphocytes) to correlate iatrogenic complications and radiation doses to normal tissues with biologic, phenotypic and genetic data. These collections will be used to: - identify factors associated with susceptibility to radiation-induced complications in normal tissues; - study radiation fibrosis biology; - study normal tissue radiosensitivity: rectal wall; - study the biological control dose-response relationship for prostate adenocarcinoma; - implement radiogenic fibrosis treatment protocols.","abstract":"","coll_dates":[{"start":"2008-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Grand Est']","analysis_unit":"Individuals","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Male\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"Female\",\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\": \"Young Adult (19 to 24 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adult (25 to 44 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Middle Aged (45 to 64 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        },\n        {\n            \"value\": \"Aged (65 to 79 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Aged, 80 and over (80 years and more)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Patients treated for a prostate adenocarcinoma in the radiation department of the Jean Monnet Hospital between 2000 and 2006.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Participant-reported health data','Biological data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nHealth event\/mortality\r\nHealth care consumption and services"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through organizations (health services or institutions, schools, businesses, etc.)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Interview with the participant (including clinical)\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"< 500 individuals","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":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]},{"subject":"observational study method","values":["Cohort study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"To be decided if data may be used by academic teams. Data may not be used by industrial teams.","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"08-03-2013","lastUpdatedAuto":null,"lastUpdatedManual":"06-09-2020","isContributorPI":"No","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":"Yes","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Interviews: manual input from a paper questionnaire Clinical examinations: handwritten","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"Epinal Hospital, Vosges department"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"Blood samples","isDataInBiobank":"Yes","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}