{"doc_desc":{"title":"French Cohort of Three Major Psychiatric disorders: Schizophrenia, Bipolar disorders, and Asperger syndrome","idno":"FRESH-PEF3145-en","producers":[{"name":"Marion LEBOYER","affiliation":"UNIVERSITE PARIS EST CRETEIL VAL DE MARNE (UPEC)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF3145-en","IDno":{"metadata_no":[{"agency":"PEF","code":"3145"},{"agency":"FReSH","code":"FRESH-PEF3145"}]},"title":"French Cohort of Three Major Psychiatric disorders: Schizophrenia, Bipolar disorders, and Asperger syndrome","alternate_title":"Psy-COH"},"study_authorization":{"agency":[]},"authoring_entity":[{"name":"Marion;LEBOYER","firstname":"Marion","lastname":"LEBOYER","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/05ggc9x40","role":"organisation id"},{"title":"SIREN","uri":"199411117","role":"organisation id"}],"email":"marion.leboyer@inserm.fr","affiliationName":"UNIVERSITE PARIS EST CRETEIL VAL DE MARNE (UPEC)","PILabo":"Fondation FondaMental - UPEC - Inserm","isContact":true}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"UNIVERSITE SORBONNE PARIS NORD","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/0199hds37","role":"sponsor id"},{"title":"SIREN","uri":"199312380","role":"sponsor id"}],"role":"sponsor"},{"name":"UNIVERSITE PARIS EST CRETEIL VAL DE MARNE (UPEC)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/05ggc9x40","role":"sponsor id"},{"title":"SIREN","uri":"199411117","role":"sponsor id"}],"role":"sponsor"},{"name":"FONDATION FONDAMENTAL","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00rrhf939","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"AGENCE NATIONALE DE LA RECHERCHE (ANR)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00rbzpz17"},{"title":"SIREN","uri":"130002504"}]},{"name":"SANOFI (FRANCE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02n6c9837"},{"title":"SIREN","uri":"395030844"}]}]},"distribution_statement":{"contact":[{"name":"Marion;LEBOYER","lastname":"LEBOYER","firstname":"Marion","type":"contact","email":"marion.leboyer@inserm.fr","affiliationName":"UNIVERSITE PARIS EST CRETEIL VAL DE MARNE (UPEC)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/05ggc9x40","role":"organisation id","title":"ROR"},{"uri":"199411117","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[],"topics":[{"topic":"Psychiatry","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/3de50dee-da1c-4791-a386-56bca24a5fed"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D011570"}]},{"topic":"Addiction medicine","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/42d645e0-f58d-40ed-9917-5b227ff41a92"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D000073316"}]},{"topic":"Schizophrenia","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1683919430","title":"CIM-11"}]},{"topic":"Bipolar or related disorders","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/613065957","title":"CIM-11"}]},{"topic":"Autism spectrum disorder","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/437815624","title":"CIM-11"}]},{"topic":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Biological determinants: Genetic predisposition","vocab":"health determinant"},{"topic":"Environmental determinants: Other","vocab":"health determinant"},{"topic":"Behavioral determinants","vocab":"health determinant"},{"topic":"Socio-demographic and economic determinants","vocab":"health determinant"},{"topic":"Behavioral determinants: Addiction","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"},{"topic":"Biological determinants","vocab":"health determinant"},{"topic":"Environmental determinants","vocab":"health determinant"}],"purpose":"1. Improve our ability to offer early diagnosis and prevention through identification of valid biomarkers\/ bio-signatures of three major mental disorders 2. Identify trajectories of patients moving across stages of disorder and behavioural indicators and biomarkers predecting risk and prognosis 3. Estimate utilization of services, healthcare, societal costs and quality of life of patients suffering from these three disorders 4. Allow national and international academic collaborators or industry partners to access cohort or data collected, to accelerate scientific progress.","abstract":"","coll_dates":[{"start":"2012-01-01"}],"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\": \"Young patients -between 16 and 35 years old - with psychotic disorders (bipolar disorders dans schizophrenia), focussing on first-episodes, as well as neuro-developmental disorders (autism without mental retardation, or Aspeger, aged 3 years and upwards)\",\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 care consumption and services\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\":\"MeasurementsAndTests.Psychological\",\"vocab\":\"CESSDA\"},\"value\":\"Psychological tests\/clinical scales (depression, cognition, quality of life, etc.)\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"[1000-10000[ individuals","response_rate":"We aim to recruit 1000 bipolar, 800 schizophrenic, and 200 Asperger patients."},"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":"","conditions":"Psy-COH will allow data access to academic as well as industrial partners, thus giving birth to numerous innotiative projects","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":"01-03-2012","lastUpdatedAuto":null,"lastUpdatedManual":"10-02-2014","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[{"type":"","title":"","link":"http:\/\/www.fondation-fondamental.org\/"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Industry"],"otherFundingAgentType":["",""]},"sponsor":{"sponsorType":["Public (France)","Public (France)","Private non-profit"],"otherSponsorType":["","",""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"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":"An anomized e-medical file has been created, that allow data recording and sharing between centres. Three e-medical files (e-Fondamental) allow extensive psychaitric, somatic and cognitive assesments, conducted by trained psychiatrists, psychologists and nurses. Three e-medical files (e-bipolar, e-schizo, and e-asperger) have already been built for assesment and follow-up of each disorder which allow the implementation of a personalized approach to the care and treatment of each patient, shared with the referring clinicians (MG and psychiatrists). In addition to its clinical remits, the network has begun to develop large-scale datasets along with biobanks or repositories, linked with platforms for genotyping or brain-imaging.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"Patients will be recruited in the expert centers involved in the french network. This network is composed of 8 bipolar disorders (Bordeaux, Cr\u00e9teil, Grenoble, Marseille, Montpellier, Paris, Strasbourg, Versailles), 8 for schizophrenia (Clermont-Ferrand, Cr\u00e9teil, Lyon, Marseille, Montpellier, Paris, Strasbourg, Versailles) and 4 for Asperger syndrome (Bordeaux, Cr\u00e9teil, Paris, Toulouse)"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"NFS, blood gases, electrolytes, glycemia, lipid profile, normal liver chemistry, thyroid profile, albumin, total protein, urea, uric acid, creatinine, phosphorus, iron, serum calcium level, psychotropic dosages, ...","isDataInBiobank":true,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}