{"doc_desc":{"title":"Cohorte interventionnelle sur des patients porteurs d\u2019un cancer \u0153so-gastrique nouvellement diagnostiqu\u00e9s et na\u00effs de tout traitement","idno":"FRESH-PEF8468-fr","producers":[{"name":"Christophe MARIETTE","affiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE LILLE (CHU)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF8468-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"8468"},{"agency":"FReSH","code":"FRESH-PEF8468"}]},"title":"Cohorte interventionnelle sur des patients porteurs d\u2019un cancer \u0153so-gastrique nouvellement diagnostiqu\u00e9s et na\u00effs de tout traitement","alternate_title":"FREGAT"},"study_authorization":{"agency":[{"name":"CNIL"},{"name":"ANSM"},{"name":"CPP"},{"name":"CESREES"}]},"authoring_entity":[{"type":"investigator","name":"Christophe;MARIETTE","PILabo":"CHRU","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE LILLE (CHU)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"07469684X","role":"pi id"},{"title":"SIREN","uri":"265906719","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"","isContact":"Non"}],"oth_id":[{"name":""}],"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":"","type":"contact"}]},"study_info":{"keywords":[{"keyword":"Tumeur de l'oesophage"},{"keyword":"tumeur de l'estomac"},{"keyword":"maladies de l'oesophage"},{"keyword":"maladies du syst\u00e8me digestif"},{"keyword":"cancer oeso-gastrique"},{"keyword":"appareil digestif"},{"keyword":"base clinico-biologique"},{"keyword":"chirurgie"}],"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":"D\u00e9terminants comportementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux : Alimentation","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"}],"purpose":"Objectif Principal : 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\u2019\u0153sophage ou de l\u2019estomac de stade I \u00e0 IV, via la constitution d\u2019une base de donn\u00e9es clinico-biologiques, prospective, multicentrique fran\u00e7aise. Objectifs Secondaires : - Evaluer l\u2019impact des diff\u00e9rentes strat\u00e9gies th\u00e9rapeutiques usuelles sur la r\u00e9cidive, sur la survie et sur la qualit\u00e9 de vie. - Identifier les facteurs pr\u00e9dictifs de r\u00e9sistance aux traitements de ces patients afin d\u2019identifier les combinaisons th\u00e9rapeutiques les plus efficientes et les moins toxiques. - D\u00e9crire les caract\u00e9ristiques individuelles, sociales et comportementales des patients inclus dans l\u2019\u00e9tude. - Identifier les d\u00e9terminants individuels et collectifs ayant une influence sur les d\u00e9lais d\u2019acc\u00e8s aux soins et de mise en route des traitements. - Identifier de nouveaux facteurs pronostiques et pr\u00e9dictifs de rechute.","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 sup\u00e9rieur(e) ou \u00e9gal \u00e0 18 ans. - Pr\u00e9sentant un cancer \u0153sophagien, de la jonction \u0153sogastrique ou gastrique nouvellement 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 biologiques','Donn\u00e9es socio-d\u00e9mographiques']","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\nConsommation de soins\/services de sant\u00e9\r\nQualit\u00e9 de vie\/sant\u00e9 per\u00e7ue\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\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":">= 20000 individus","response_rate":"135 patients au 20\/01\/2015"},"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":"Aucune publication ou pr\u00e9sentation des r\u00e9sultats de cet essai ne pourra \u00eatre effectu\u00e9e sans l\u2019accord du promoteur (CHRU de Lille) et de l\u2019investigateur coordonnateur.","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":"24-03-2014","lastUpdatedAuto":null,"lastUpdatedManual":"31-07-2014","isContributorPI":"Non","contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":["","","",""]},"relatedDocument":[{"type":"","title":"","link":"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/25062398"},{"type":"","title":"Lien des publications Pubmed","link":"http:\/\/tinyurl.com\/FREGAT"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"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":"Le recueil des donn\u00e9es cliniques, biologiques, \u00e9pid\u00e9miologiques ainsi que les caract\u00e9ristiques des traitements des patients seront recueillies dans le cahier d\u2019observation \u00e9lectronique (e-CRF) de l\u2019\u00e9tude","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"France m\u00e9tropolitaine (33 centres, 46 \u00e9quipes)"},"dataTypes":{"clinicalDataDetails":"Recueil dans un e-crf de : - variables cliniques (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\u2026)- variables pathologiques (biopsies pr\u00e9-th\u00e9rapeutiques, biopsies post-th\u00e9rapeutiques, banque de tumeurs, localisation, stade pTNM, donn\u00e9es pathologiques, observation de marqueurs de r\u00e9sistance aux traitements, m\u00e9tastases, r\u00e9gression, progression, r\u00e9currence, histologie, effet du traitement n\u00e9o-adjuvant\u2026)- variables th\u00e9rapeutiques : : strat\u00e9gie th\u00e9rapeutique, chimioth\u00e9rapie, chirurgie, radioth\u00e9rapie, \u00e9valuation de la r\u00e9ponse et de la tol\u00e9rance.","biologicalDataDetails":"- une collection d\u2019\u00e9chantillons tumoraux (biopsies pr\u00e9-th\u00e9rapeutiques, biopsies post-th\u00e9rapeutiques, pi\u00e8ces op\u00e9ratoires) collect\u00e9e en respectant les chartes qualit\u00e9 en vigueur. Ces \u00e9chantillons seront conserv\u00e9s, dans le centre investigateur correspondant, id\u00e9alement en cong\u00e9lation, mais \u00e0 d\u00e9faut la conservation en paraffine sera accept\u00e9e.- une collection d\u2019\u00e9chantillons sanguins dont la mise en place est pr\u00e9vue dans 6 centres \u00e0 fort potentiel de recrutement et poss\u00e9dant un Centre de Ressources Biologique (CRB) (soit environ 3000 patients) . Ces CRB labellis\u00e9s assureront le contr\u00f4le qualit\u00e9 des \u00e9chantillons comme usuellement.","isDataInBiobank":"Oui","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}