{"study_desc":{"title_statement":{"idno":"FRESH-PEF38993-en","IDno":{"metadata_no":[{"agency":"PEF","code":"38993"},{"agency":"FReSH","code":"FRESH-PEF38993"}]},"title":"Anatomical-Clinical Pancreatic Adenocarcinoma Database","alternate_title":"BACAP"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Barbara;BOURNET","firstname":"Barbara","lastname":"BOURNET","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/017h5q109","role":"organisation id"},{"title":"SIREN","uri":"263100125","role":"organisation id"},{"uri":"0000-0002-3679-9454","role":"pi id","title":"ORCID"},{"uri":"083302158","role":"pi id","title":"IdRef"}],"email":"bournet.b@chu-toulouse.fr","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE (CHUT)","PILabo":"CHU Toulouse \/ Gastro-ent\u00e9rologie et nutrition","isContact":true},{"name":"Cindy;CANIVET","firstname":"Cindy","lastname":"CANIVET","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/017h5q109","role":"organisation id"},{"title":"SIREN","uri":"263100125","role":"organisation id"},{"uri":"140253157","role":"pi id","title":"IdRef"}],"email":"canivet.c@chu-toulouse.fr","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE (CHUT)","PILabo":"CHU Toulouse","isContact":true}],"oth_id":[{"name":"BACAP consists of a network of clinicians (physicians and surgeons), anatomical pathologists, epidemiologists, and researchers","type":"collaboration"}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE (CHUT)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/017h5q109","role":"sponsor id"},{"title":"SIREN","uri":"263100125","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":"Barbara;BOURNET","lastname":"BOURNET","firstname":"Barbara","type":"contact","email":"bournet.b@chu-toulouse.fr","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE (CHUT)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/017h5q109","role":"organisation id","title":"ROR"},{"uri":"263100125","role":"organisation id","title":"SIREN"}]},{"name":"Cindy;CANIVET","lastname":"CANIVET","firstname":"Cindy","type":"contact","email":"canivet.c@chu-toulouse.fr","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE (CHUT)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/017h5q109","role":"organisation id","title":"ROR"},{"uri":"263100125","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Clinical data"},{"keyword":"biological specimens"},{"keyword":"pancreatic carcinogenesis"},{"keyword":"therapeutic target"},{"keyword":"cachexia"},{"keyword":"biomarker"},{"keyword":"proteomics signature"},{"keyword":"genomic DNA"},{"keyword":"microparticles"},{"keyword":"diagnosis"},{"keyword":"screening"},{"keyword":"microRNA"}],"topics":[{"topic":"Oncology","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/5784b7f1-c7ce-49d9-9f38-aebcda0ff41d"},{"title":"MeSH","uri":"D008495"}]},{"topic":"Gastroenterology","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/a3898340-a42d-4f5e-a822-1de204a9a867"},{"title":"MeSH","uri":"D005762"}]},{"topic":"Malignant neoplasms, stated or presumed to be primary, of specified sites, except of lymphoid, haematopoietic, central nervous system or related tissues","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1643222460","title":"CIM-11"}]},{"topic":"Biological determinants: Genetic predisposition","vocab":"health determinant"},{"topic":"Behavioral determinants","vocab":"health determinant"},{"topic":"Behavioral determinants: Eating habits","vocab":"health determinant"},{"topic":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Socio-demographic and economic determinants: Employment","vocab":"health determinant"},{"topic":"Biological determinants","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"},{"topic":"Socio-demographic and economic determinants","vocab":"health determinant"}],"purpose":"The purpose of this project is to compile clinical data and data on biological specimens from patients with a pancreatic adenocarcinoma in order to make it available to the scientific community. The purpose of BACAP is to support the following research projects: - understanding the development of pancreatic carcinogenesis, - the early diagnosis and screening of pancreatic cancer by identifying biomarkers of precancerous lesions (proteomics signature, microRNA, genomic dNA, microparticles) and associated thrombosis risk, - the development of new in vitro tools for diagnosing pancreatic cancer, - the clinical and biological evaluation of the development of cachexia in patients with pancreatic cancer, - the determination of factors responsible for spreading cancerous cells, especially inflammation markers, - the identification of biomarkers that indicate sensitivity or resistance to chemotherapy in pancreatic cancer, - the development of new therapeutic targets","abstract":"","coll_dates":[{"start":"2014-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individuals","universe":"{\"level_sex_clusion_I\":[{\"value\":\"Male\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D008297\"}},{\"value\":\"Female\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D005260\"}}],\"level_age_clusion_I\":[{\"value\":\"Young Adult (19 to 24 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D055815\"}},{\"value\":\"Adult (25 to 44 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000328\"}},{\"value\":\"Middle Aged (45 to 64 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D008875\"}},{\"value\":\"Aged (65 to 79 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000368\"}},{\"value\":\"Aged, 80 and over (80 years and more)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000369\"}}],\"level_type_clusion_I\":\"Patients population\",\"level_type_clusion_other\":\"\",\"clusion_I\":\"Patients with cytologically and\/or histologically proven pancreatic adenocarcinoma\",\"clusion_E\":\"\"}","data_kind":"['Clinical data','Paraclinical data (non-biological)','Paraclinical data (non-biological) : Imaging','Paraclinical data (non-biological) : Other','Biological data','Participant-reported health data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Clinsight software, the database is managed by the ICM data handling centre']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/mortality"}]},"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\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"[1000-10000[ individuals","response_rate":"1250"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}","notes":""},"dataset_use":{"restrictions":"","conditions":"The data and the biological specimens are accessible upon request. The request form is accessible on the database website. Each request will be examined by the database's scientific committee.","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""}}},"additional":{"versionLang":"en","originLang":"en","autoTranslation":false,"status":"Imported","creationDate":"02-04-2015","lastUpdatedManual":"07-08-2019","isContributorPI":"","contributorName":"Barbara BOURNET","contributorAffiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE (CHUT)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":true},"collaborations":{"networkConsortium":true},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":true,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"During patient visits to the corresponding hospital. Collection by clinicians (gastroenterologists, oncologists, surgeons)","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"15 centres : Toulouse (CHU de Toulouse), Montpellier (Institut r\u00e9gional du Cancer de Montpellier et CHU de Montpellier), Marseille (Assistance Publique des H\u00f4pitaux de Marseille - h\u00f4pital Nord et hopital La Timone), Nice (CHU de Nice - h\u00f4pital l\u2019Archet), Lyon (h\u00f4pital priv\u00e9 Jean Mermoz et Centre L\u00e9on B\u00e9rard), Villejuif (Institut Gustave Roussy), Paris (Assistance Publique des H\u00f4pitaux de Paris - h\u00f4pital Saint-Louis), Paris (Clinique du Trocadero), Lille (CHRU de Lille), Bordeaux (CHU de Bordeaux), Pau (CH de Pau)"},"dataTypes":{"clinicalDataDetails":"Imaging, biological assessment, clinical examination, treatments and side effects, weight progression, height, WHO performance index, medical comorbidities, history of other cancers, the date of first symptoms\/description, diagnosis, tumour","biologicalDataDetails":"CBC, liver panel, glycaemia, tumoural markers","isDataInBiobank":true,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}