{"doc_desc":{"title":"Annotator\u00ae, Base de donn\u00e9es du Programme \"Cartes d\u2019Identit\u00e9 des Tumeurs (CIT)\u00ae \"","idno":"FRESH-PEF8214-fr","producers":[{"name":"Fabien PETEL","affiliation":"LIGUE NATIONALE CONTRE LE CANCER (LNCC)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF8214-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"8214"},{"agency":"FReSH","code":"FRESH-PEF8214"}]},"title":"Annotator\u00ae, Base de donn\u00e9es du Programme \"Cartes d\u2019Identit\u00e9 des Tumeurs (CIT)\u00ae \"","alternate_title":"Annotator\u00ae"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Mira;AYADI","PILabo":"Ligue Nationale Contre le Cancer \/ CIT \/ Recherche","affiliationName":"LIGUE NATIONALE CONTRE LE CANCER (LNCC)","extlink":[{"title":"ORCID","uri":"0000-0002-4019-2858","role":"pi id"},{"title":"IdRef","uri":"078449448","role":"pi id"},{"title":"SIREN","uri":"775664717","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"Mira.Ayadi@ligue-cancer.net","isContact":"Oui"},{"type":"investigator","name":"Aur\u00e9lien;DE REYNIES","PILabo":"Ligue Nationale Contre le Cancer \/ CIT \/ Recherche","affiliationName":"LIGUE NATIONALE CONTRE LE CANCER (LNCC)","extlink":[{"title":"ORCID","uri":"0000-0002-1328-5290","role":"pi id"},{"title":"IdRef","uri":"119941848","role":"pi id"},{"title":"SIREN","uri":"775664717","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"","isContact":"Non"},{"type":"investigator","name":"Fabien;PETEL","PILabo":"Ligue Nationale Contre le Cancer \/ CIT \/ Recherche","affiliationName":"LIGUE NATIONALE CONTRE LE CANCER (LNCC)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"092796044","role":"pi id"},{"title":"SIREN","uri":"775664717","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"Fabien.Petel@ligue-cancer.net","isContact":"Oui"}],"oth_id":[{"name":"Plus de 80 projets de recherche ont \u00e9t\u00e9 men\u00e9s dans le cadre du programme CIT, sur plus de 20 types de cancer diff\u00e9rents, et ont conduit \u00e0 de nombreuses publications dans des revues internationales.","type":"collaboration"}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"LIGUE NATIONALE CONTRE LE CANCER (LNCC)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00rkrv905","role":"sponsor id"},{"title":"SIREN","uri":"775664717","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":"","extlink":[]},{"name":"","extlink":[]}]},"distribution_statement":{"contact":[{"name":"Mira;AYADI","email":"Mira.Ayadi@ligue-cancer.net","type":"contact","affiliationName":"LIGUE NATIONALE CONTRE LE CANCER (LNCC)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/00rkrv905","role":"organisation id","title":"ROR"},{"uri":"775664717","role":"organisation id","title":"SIREN"}]},{"name":"Fabien;PETEL","email":"Fabien.Petel@ligue-cancer.net","type":"contact","affiliationName":"LIGUE NATIONALE CONTRE LE CANCER (LNCC)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/00rkrv905","role":"organisation id","title":"ROR"},{"uri":"775664717","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Ligue Nationale contre le Cancer"},{"keyword":"alt\u00e9rations"},{"keyword":"g\u00e9nome"},{"keyword":"r\u00e9arrangements chromosomiques"},{"keyword":"expression des g\u00e8nes"},{"keyword":"microARNs"},{"keyword":"patterns de m\u00e9thylation"},{"keyword":"exons"},{"keyword":"cellules canc\u00e9reuses"},{"keyword":"m\u00e9decine personnalis\u00e9e"},{"keyword":"mutations"}],"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":"Immunologie m\u00e9dicale","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":"Tumeurs","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1630407678","title":"CIM-11"}]},{"topic":"D\u00e9terminants comportementaux : Addictions","vocab":"health determinant"},{"topic":"D\u00e9terminants biologiques : Pr\u00e9dispositions g\u00e9n\u00e9tiques","vocab":"health determinant"},{"topic":"D\u00e9terminants environnementaux : Autres","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"},{"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 biologiques","vocab":"health determinant"},{"topic":"D\u00e9terminants environnementaux","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":"Caract\u00e9riser de fa\u00e7on exhaustive et combin\u00e9e les alt\u00e9rations du g\u00e9nome \u00e0 l\u2019origine des cancers (mutations et r\u00e9arrangements chromosomiques, expression des g\u00e8nes et des microARNs, patterns de m\u00e9thylation, variations des exons, etc.) CIT d\u00e9veloppe ainsi une vision int\u00e9gr\u00e9e du fonctionnement des cellules canc\u00e9reuses, et ces travaux constituent la base d\u2019une m\u00e9decine personnalis\u00e9e, adapt\u00e9e aux caract\u00e9ristiques g\u00e9nomiques de chaque tumeur.","abstract":"","coll_dates":[{"start":"2000-01-01","end":"2014-01-01"}],"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\": \"Nouveau-n\u00e9 (naissance \u00e0 28j)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D007231\"\n            }\n        },\n        {\n            \"value\": \"Nourrisson (28j \u00e0 2 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D007223\"\n            }\n        },\n        {\n            \"value\": \"Petite enfance (2 \u00e0 5 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002675\"\n            }\n        },\n        {\n            \"value\": \"Enfance (6 \u00e0 12 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002648\"\n            }\n        },\n        {\n            \"value\": \"Adolescence (13 \u00e0 18 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000293\"\n            }\n        },\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\": \"Les crit\u00e8res d\u2019inclusion sont sp\u00e9cifiques \u00e0 chaque projet accept\u00e9 dans le Programme CIT, et d\u00e9pendent des questions biologiques et cliniques des porteurs de projet associ\u00e9s. Les \u00e9tudes peuvent concerner des patients suivis en milieu hospitalier, ou des patients d\u00e9j\u00e0 inclus dans un essai clinique prospectif. Le consentement \u00e9clair\u00e9 des patients a \u00e9t\u00e9 obtenu auparavant. Les pathologies \u00e9tudi\u00e9es sont soit des tumeurs p\u00e9diatriques, soit des cancers de l\u2019adulte, et peuvent concerner aussi bien des tumeurs solides que des h\u00e9mopathies malignes ou des lymphomes. L\u2019acc\u00e8s aux donn\u00e9es est s\u00e9curis\u00e9, et restreint pour chaque projet aux investigateurs concern\u00e9s.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es paracliniques','Donn\u00e9es biologiques']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"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\nAutres"}]},"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\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Transcription et saisie d\u2019informations dans un enregistrement structur\u00e9\"}","{\"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":"[10000-20000[ individus","response_rate":"Fin 2013, la base de donn\u00e9es \u2018Annotator\u2019 du Programme CIT contenait les informations histologiques, cliniques, biologiques de 11000 \u00e9chantillons tumoraux (patients anonymis\u00e9s), tous types de cancer confondus, et 18000 exp\u00e9riences haut-d\u00e9bit avaient \u00e9t\u00e9 r\u00e9alis\u00e9es."},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]}]},"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":"L\u2019acc\u00e8s aux donn\u00e9es est s\u00e9curis\u00e9, et restreint pour chaque projet aux investigateurs concern\u00e9s.","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":"27-02-2014","lastUpdatedAuto":null,"lastUpdatedManual":"13-03-2014","isContributorPI":"Non","contributorName":"Fabien PETEL","contributorAffiliation":"LIGUE NATIONALE CONTRE LE CANCER (LNCC)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"","link":"http:\/\/cit.ligue-cancer.net\/?page_id=59"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Priv\u00e9 \u00e0 but non lucratif","Autre","Public (France)"],"otherFundingAgentType":["","",""]},"sponsor":{"sponsorType":["Priv\u00e9 \u00e0 but non lucratif"],"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":"","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"France"},"dataTypes":{"clinicalDataDetails":"--","biologicalDataDetails":"pr\u00e9sence d'ad\u00e9nomes. Morphologie cellulaire, diff\u00e9renciation, fibroses, mitoses, n\u00e9croses. Pourcentage de cellules tumorales. Hyperplasie. AFP. Albumine. ALP. B2 microglobuline. Bilirubine. CEA. LDH. Metanephrine. PSA. Taux de s\u00e9dimentation. Creatinine. Leucocytes.","isDataInBiobank":"Oui","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}