{"doc_desc":{"title":"Cohort of Patients with HIV Associated Lymphoma","idno":"FRESH-PEF60062-en","producers":[{"name":"Caroline BESSON","affiliation":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60062-en","IDno":{"metadata_no":[{"agency":"PEF","code":"60062"},{"agency":"FReSH","code":"FRESH-PEF60062"}]},"title":"Cohort of Patients with HIV Associated Lymphoma","alternate_title":"ANRS CO16 LYMPHOVIR"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Caroline;BESSON","PILabo":"AP-HP \/ SERVICE D'H\u00c9MATOLOGIE, IMMUNOLOGIE BIOLOGIQUE (PR MARTINE RAPHA\u00cbL) H\u00d4PITAL DE BIC\u00caTRE 78, RUE DU G\u00c9N\u00c9RAL LECLERC, 94275 LE KREMLIN-BIC\u00caTRE C\u00c9DEX","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"ORCID","uri":"0000-0003-4364-7173","role":"pi id"},{"title":"IdRef","uri":"096287608","role":"pi id"},{"title":"SIREN","uri":"267500452","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"cbesson@ch-versailles.fr","isContact":"Yes"},{"type":"investigator","name":"Dominique;COSTAGLIOLA","PILabo":"INSERM - Institut National de Sant\u00e9 et Recherche \/ INSERM U943 EPIDEMIOLOGIE, STRAT\u00c9GIES TH\u00c9RAPEUTIQUES ET VIROLOGIE CLINIQUES DANS L'INFECTION \u00c0 VIH 56 BD V AURIOL, BP 335, 75625 PARIS CEDEX 13, France","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ORCID","uri":"0000-0003-0765-0869","role":"pi id"},{"title":"IdRef","uri":"109189108","role":"pi id"},{"title":"SIREN","uri":"180036048","role":"organisation id"},{"title":"RNSR","uri":"201420917E","role":"labo id"}],"email":"","isContact":"No"}],"oth_id":[{"name":"","type":""},{"name":"","type":""}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"AGENCE NATIONALE DE RECHERCHES SUR LE SIDA ET LES HEPATITES VIRALES (ANRS MIE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01kv58h76","role":"sponsor id"},{"title":"SIREN","uri":"180089385","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"AGENCE NATIONALE DE RECHERCHES SUR LE SIDA ET LES HEPATITES VIRALES (ANRS MIE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01kv58h76"},{"title":"SIREN","uri":"180089385"}]}]},"distribution_statement":{"contact":[{"name":"Caroline;BESSON","email":"cbesson@ch-versailles.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":"event-free survival"},{"keyword":"Health episodes"},{"keyword":"overall survival"},{"keyword":"quality of life"}],"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":"Cardiology and vascular medicine","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/4455c187-2f2f-4cd1-a4dd-449f59d73b39"},{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/c42fc6ec-b216-4a24-9e9d-f5e781c175a0"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D002309"}]},{"topic":"Clinical immunology","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/7a3cf568-46ba-4840-be8f-f22fc030139f"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D000486"}]},{"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":"Biological determinants: Genetic predisposition","vocab":"health determinant"},{"topic":"Biological determinants","vocab":"health determinant"}],"purpose":"General objective: to better understand the physiopathology of non-Hodgkin lymphoma (NHL) and Hodgkin lymphoma (HL) associated with HIV by studying, on the one hand, interaction between Epstein-Barr virus (EBV) and HIV infection from a virological and immunological viewpoint and, on the other hand, the role of chronic antigen stimulation. Secondary objectives: - Clinical and histological characterisation of lymphoma; - to undertake an observational study on the treatment and outcome for these patients in terms of antiretroviral therapy; - to create a forum concerning therapeutic care for these patients; - To enable \"Lymphoma and HIV\" studies developed by the ANRS group: (1) Clinical: (a) To define prognostic factors for unfavourable progression of NHL and HL (b) To develop target treatment consensus according to histology and clinical presentation for patients included in the cohort (2) Anatomical and clinical: to characterise lymphoproliferations and investigate the presence and reactivation of EBV in these tumours (3) Immunological: to study anti-EBV immune T cell response and their role in the pathophysiology of EBV-related lymphomas, to characterise the activation status of circulating B cells (4) Virological: to quantify viral load and anti-EBV antibody titres, to genotype EBV variants for HL patients, to study the replication of EBV in B lymphocyte memory, to investigate the interaction of TGF-induced EBV replication and cell survival in tumour cells infected by EBV (5) Molecular: to study the \"microsatellite instability\" (MSI) phenotype of these tumours.","abstract":"","coll_dates":[{"start":"2008-01-01","end":"2018-01-01"}],"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    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Adults (18 years old); - infected by HIV-1 or HIV-2; - NHL or HL diagnosis or relapse (including cerebral lymphoma); - who have given clear and written consent.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Participant-reported health data','Biological data','Paraclinical data (non-biological) : Imaging']","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\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\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Self-administered questionnaire\"}","{\"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":"150"},"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":"Data may be used by academic teams. Data may not be used by industrial teams.","conditions":"Access to all or part of the study database will be specified by the scientific council and subject to the agreement of the sponsor.","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":"20-06-2025","isContributorPI":"No","contributorName":"Caroline BESSON","contributorAffiliation":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[{"type":"","title":"Liste des publications dans Pubmed","link":"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/?term=ANRS+CO16+OR+LYMPHOVIR"}],"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":"Self-administered questionnaire: input from a paper questionnaire (manual input) Clinical Examination: handwritten (manual input) with double data entry Biological analysis: handwritten (manual input) with double data entry","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"Multicentric cohort throughout France (35 centres)"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"Type of samples taken: whole blood (60 ml), saliva, sample for lymphoma diagnosis","isDataInBiobank":"Yes","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}