{"doc_desc":{"title":"Base de donn\u00e9es fran\u00e7aise des cancers oeso-gastriques","idno":"FRESH-PEF73435-fr","producers":[{"name":"St\u00e9phanie DEVAUX","affiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE LILLE (CHU)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73435-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"73435"},{"agency":"FReSH","code":"FRESH-PEF73435"}]},"title":"Base de donn\u00e9es fran\u00e7aise des cancers oeso-gastriques","alternate_title":"FREGAT"},"study_authorization":{"agency":[{"name":"CNIL"},{"name":"CPP"},{"name":"ANSM"}]},"authoring_entity":[{"type":"investigator","name":"St\u00e9phanie;DEVAUX","PILabo":"CHU de Lille","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE LILLE (CHU)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"197082890","role":"pi id"},{"title":"SIREN","uri":"265906719","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"stephanie.devaux@chru-lille.fr","isContact":"Oui"},{"type":"investigator","name":"Guillaume;PIESSEN","PILabo":"CHU de Lille","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE LILLE (CHU)","extlink":[{"title":"ORCID","uri":"0000-0001-8243-8310","role":"pi id"},{"title":"IdRef","uri":"117029459","role":"pi id"},{"title":"SIREN","uri":"265906719","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"guillaume.piessen@chru-lille.fr","isContact":"Oui"},{"type":"investigator","name":"Florence;RENAUD","PILabo":"CHU de Lille","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE LILLE (CHU)","extlink":[{"title":"ORCID","uri":"0000-0003-3614-1713","role":"pi id"},{"title":"IdRef","uri":"280804024","role":"pi id"},{"title":"SIREN","uri":"265906719","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"florence.renaud@chru-lille.fr","isContact":"Oui"}],"oth_id":[{"name":"38 centres nationaux participent au projet FREGAT, constituant un r\u00e9seau de m\u00e9decins, chirurgiens, anatomopathologistes, biologistes et chercheurs","type":"collaboration"}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE LILLE (CHU)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02ppyfa04","role":"sponsor id"},{"title":"SIREN","uri":"265906719","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"INSTITUT NATIONAL DU CANCER (INCA)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/03m8vkq32"},{"title":"SIREN","uri":"187512777"}]}]},"distribution_statement":{"contact":[{"name":"St\u00e9phanie;DEVAUX","email":"stephanie.devaux@chru-lille.fr","type":"contact","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE LILLE (CHU)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/02ppyfa04","role":"organisation id","title":"ROR"},{"uri":"265906719","role":"organisation id","title":"SIREN"}]},{"name":"Guillaume;PIESSEN","email":"guillaume.piessen@chru-lille.fr","type":"contact","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE LILLE (CHU)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/02ppyfa04","role":"organisation id","title":"ROR"},{"uri":"265906719","role":"organisation id","title":"SIREN"}]},{"name":"Florence;RENAUD","email":"florence.renaud@chru-lille.fr","type":"contact","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE LILLE (CHU)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/02ppyfa04","role":"organisation id","title":"ROR"},{"uri":"265906719","role":"organisation id","title":"SIREN"}]},{"name":"Antoine;ADENIS","email":"antoine.adenis@icm.unicancer.fr","type":"contact","affiliationName":"INSTITUT REGIONAL DU CANCER DE MONTPELLIER (ICM)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/02693j602","role":"organisation id","title":"ROR"},{"uri":"788214963","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"sciences humaines et sociales"},{"keyword":"Donn\u00e9es cliniques"},{"keyword":"\u00e9chantillons biologiques"},{"keyword":"cancer oeso-gastrique"},{"keyword":"biomarqueurs"},{"keyword":"cible th\u00e9rapeutique"},{"keyword":"strat\u00e9gie th\u00e9rapeutique"},{"keyword":"qualit\u00e9 de vie"}],"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":"Gastroent\u00e9rologie","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":"Tumeurs malignes, d\u00e9clar\u00e9es ou suppos\u00e9es primitives, de localisations pr\u00e9cis\u00e9es, \u00e0 l'exception des tissus lympho\u00efde, h\u00e9matopo\u00ef\u00e9tique, du syst\u00e8me nerveux central ou de tissus apparent\u00e9s","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1643222460","title":"CIM-11"}]},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques","vocab":"health determinant"},{"topic":"D\u00e9terminants biologiques : Pr\u00e9dispositions g\u00e9n\u00e9tiques","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":"Syst\u00e8mes de soins et acc\u00e8s aux soins","vocab":"health determinant"},{"topic":"D\u00e9terminants biologiques","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"}],"purpose":"Identifier les facteurs cliniques, biologiques et tumoraux li\u00e9s \u00e0 la r\u00e9sistance aux traitements anti-tumoraux chez les patients trait\u00e9s pour un cancer de l\u2019oesophage ou de l\u2019estomac de stade I \u00e0 IV, via la constitution d\u2019une base de donn\u00e9es clinico-biologique, prospective, multicentrique fran\u00e7aise.","abstract":"","coll_dates":[{"start":"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\": \"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\": \" Homme ou femme \u2265 18 ans. - Pr\u00e9sentant un cancer oesophagien, de la jonction oesogastrique ou gastrique diagnostiqu\u00e9 par biopsie, quelque soit le sous-type de cancer, le stade tumoral ou le traitement envisag\u00e9. - Na\u00eff de traitement pour le pr\u00e9sent cancer, \u00e0 d\u00e9faut ayant re\u00e7u un traitement n\u00e9oadjuvant. - B\u00e9n\u00e9ficiant d\u2019un r\u00e9gime de protection sociale. - Ayant sign\u00e9 le consentement libre et \u00e9clair\u00e9 pour les pr\u00e9l\u00e8vements sanguins, les diff\u00e9rents questionnaires et la collecte d\u2019informations patient.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude','Donn\u00e9es paracliniques','Donn\u00e9es biologiques']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Logiciel Ennov clinical, base de donn\u00e9es g\u00e9r\u00e9e par le CHU de Lille']"}},"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\nQualit\u00e9 de vie\/sant\u00e9 per\u00e7ue"}]},"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":"[10000-20000[ individus","response_rate":"15000"},"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":"","conditions":"Les modalit\u00e9s d'acc\u00e8s et d'utilisation des ressources issues de la cohorte FREGAT sont d\u00e9taill\u00e9es par la Charte de la Cohorte FREGAT t\u00e9l\u00e9chargeable sur le site internet FREGAT. Le dossier de soumission d'un projet scientifique (t\u00e9l\u00e9chargeable sur le site), une fois finalis\u00e9, est \u00e0 soumettre \u00e0 contact@fregat-database.org. Le projet sera expertis\u00e9 par le conseil scientifique restreint au regard de l\u2019int\u00e9r\u00eat scientifique du projet et de sa faisabilit\u00e9. Le rapport d'expertise et la grille financi\u00e8re sera ensuite envoy\u00e9 au porteur de projet.","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":"09-11-2020","lastUpdatedAuto":null,"lastUpdatedManual":"04-02-2021","isContributorPI":"Non","contributorName":"St\u00e9phanie DEVAUX","contributorAffiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE LILLE (CHU)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":["","",""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)"],"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":"Recueil des donn\u00e9es lors des visites du patient dans le centre","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"38 Centres: CHU de Lille, Centre Oscar Lambret Lille, Centre Hospitalier Lyon Sud, H\u00f4pital Croix Rousse Lyon, H\u00f4pital E. Herriot Lyon, CHU de Marseille, Institut Paoli Calmettes Marseille, Institut Gustave Roussy Villejuif, CHU de Bordeaux, CHU de Toulouse, Institut C. Regaud Toulouse, H\u00f4pital Europ\u00e9en Georges Pompidou Paris, CHU de Strasbourg, CHU de Montpellier, Institut R\u00e9gional du cancer de Montpellier, H\u00f4pital St Antoine Paris, H\u00f4pital Avicenne, H\u00f4pital Beaujon, H\u00f4pital Kremlin Bic\u00eatre, H\u00f4pital Lariboisi\u00e8re Paris, H\u00f4pital la Piti\u00e9 Salp\u00eatri\u00e8re Paris, H\u00f4pital Ambroise Par\u00e9 Boulogne-Billancourt, CHU de St Etienne, Centre Antoine Lacassagne Nice, CHU de Nice, CHU de Clermont Ferrand, Centre Jean Perrin Clermont Ferrand, CHU de N\u00eemes, CHU de Nancy, Centre Alexis Vautrin Nancy, CHU de Reims, CHU de Dijon, Centre Gearges Fran\u00e7ois Leclerc Dijon, CHU d'Amiens, CHU de Limoges, CHU de Nantes, Centre F. Baclesse Caen, CHU de Caen, CHU de Rouen, CHU de Grenoble, CHU de Tours, H\u00f4pital de Colombes, CHU de Brest, CHU de Rennes, Centre Eug\u00e8ne Marquis Rennes, H\u00f4pital Cochin Paris, H\u00f4pital St Louis Paris, CHU Jean Minjoz Besan\u00e7on, CLCC St Catherine Avignon, Institut Canc\u00e9rologie de l'Ouest Ren\u00e9 Gauducheau Nantes"},"dataTypes":{"clinicalDataDetails":"poids, taille, co-morbidit\u00e9, date du premier sympt\u00f4me \/ description, date de premi\u00e8re consultation, type de sp\u00e9cialiste consult\u00e9, fr\u00e9quence des consultations (g\u00e9n\u00e9raliste \/ sp\u00e9cialiste), m\u00e9dications concomitantes, param\u00e8tres nutritionnels, alcool et tabac, reflux, ob\u00e9sit\u00e9, habitudes alimentaires, toxicit\u00e9s","biologicalDataDetails":"collections de variables inflammatoires, nutritionnelles","isDataInBiobank":"Oui","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}