{"doc_desc":{"title":"Cohort of High-Grade AIN3 Anal Dysplasia","idno":"FRESH-PEF8099-en","producers":[{"name":"Nathalie GAULT","affiliation":"UNIVERSITE PARIS CITE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF8099-en","IDno":{"metadata_no":[{"agency":"PEF","code":"8099"},{"agency":"FReSH","code":"FRESH-PEF8099"}]},"title":"Cohort of High-Grade AIN3 Anal Dysplasia","alternate_title":""},"study_authorization":{"agency":[]},"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":"Yes"}],"oth_id":[{"name":"","type":""},{"name":"","type":""}],"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":"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":"High-grade anal dysplasia (AIN3)"},{"keyword":"epidermoid carcinoma of the anus"},{"keyword":"risk factors"}],"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":"Infectious disease medicine","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":"Gastroenterology","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":"Carcinoma in situ of other or unspecified digestive organs","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1277122723","title":"CIM-11"}]},{"topic":"Behavioral determinants","vocab":"health determinant"}],"purpose":"The main objective of the study is the evaluation of 3-year anal carcinoma incidence in patients with anal AIN3 lesions. Secondary objectives are: - To identify patients with an anal AIN3 lesion, risk factors (demographical data, HIV status...), treatment factors (type of therapeutic treatment), virological and immunological factors (HPV genotype, presence or non-presence of P16 and Ki67 proteins) associated with the onset of epidermoid carcinoma of the anus.- To identify if the presence of P16\/Ki67 factors and high risk HPV virus is associated with an increased risk of recurrent AIN3 lesions and if this is the case for high-grade dysplasia of the cervix. - To estimate the proportion of adherent patients, and to identify factors associated with compliance monitoring (demographics, HIV status, type of treatment undertaken ...) - to assess the overall feeling of patients towards anal AIN3 lesion therapeutic care.","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":"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\": \"Anal AIN3 lesion diagnosed by histology: - aposteriori for patients with a history of anal AIN3 complicated or not complicated by anal cancer. These cases will be identified from data bases of anatomopathology laboratories in hospitals since 1st January 2000. - patients consulting a proctologist at time of diagnosis for first displasic anal AIN3 lesion.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Biological data','Paraclinical data (non-biological) : Imaging']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['monthly data management, queries on missing data or inconsistencies, median follow-up']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nHealth event\/mortality\r\nHealth care consumption and services\r\nQuality of life\/health perception"}]},"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\":\"MeasurementsAndTests.Physical\",\"vocab\":\"CESSDA\"},\"value\":\"Physical\/biological measurements (blood pressure, weight, biochemistry, imaging, etc.)\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"[500-1000[ individuals","response_rate":"865"},"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":"","conditions":"Contact the principal investigator","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":"19-02-2014","lastUpdatedAuto":null,"lastUpdatedManual":"09-09-2020","isContributorPI":"No","contributorName":"Nathalie GAULT","contributorAffiliation":"UNIVERSITE PARIS CITE","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Private non-profit","Industry","Industry","Private non-profit","Private non-profit","Private non-profit"],"otherFundingAgentType":["","","","","",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":"Yes"},"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":"Data collected retrospectively and prospectively by the proctologist in charge of the medical examination and follow-up consultation.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"35 specialist patient treatment centres throughout metropolitan France"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"Biological components: - anal smear - biopsy of lesions - cytology - histological analysis - Ki67 and P16 protein research - research and genotyping of HPV virus","isDataInBiobank":"Yes","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}