{"doc_desc":{"title":"Cohort Belonging to The National Network of Schizophrenia Expert Centres","idno":"FRESH-PEF73248-en","producers":[{"name":"","affiliation":""}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73248-en","IDno":{"metadata_no":[{"agency":"PEF","code":"73248"},{"agency":"FReSH","code":"FRESH-PEF73248"}]},"title":"Cohort Belonging to The National Network of Schizophrenia Expert Centres","alternate_title":"FACE-SZ"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Marion;LEBOYER","PILabo":"Inserm U955 team 15 AP-HP Mondor University Hospital, DHU Pe-Psy, Cr\u00e9teil, France \/ Inserm U955 team 15 AP-HP Mondor University Hospital, DHU Pe-Psy, Cr\u00e9teil, France","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"ORCID","uri":"0000-0001-5473-3697","role":"pi id"},{"title":"IdRef","uri":"089352475","role":"pi id"},{"title":"SIREN","uri":"267500452","role":"organisation id"},{"title":"RNSR","uri":"200919261B","role":"labo id"}],"email":"marion.leboyer@inserm.fr","isContact":"Yes"},{"type":"investigator","name":"Pierre-Michel;LLORCA","PILabo":"Clermont-Ferrand University Hospital, France \/ Clermont-Ferrand University Hospital","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE CLERMONT-FERRAND","extlink":[{"title":"ORCID","uri":"0000-0001-7438-8990","role":"pi id"},{"title":"IdRef","uri":"05967797X","role":"pi id"},{"title":"SIREN","uri":"266307461","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"pmllorca@chu-clermontferrand.fr","isContact":"Yes"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"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"}]}]},"distribution_statement":{"contact":[{"name":"Marion;LEBOYER","email":"marion.leboyer@inserm.fr","type":"contact","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/00pg5jh14","role":"organisation id","title":"ROR"},{"uri":"267500452","role":"organisation id","title":"SIREN"}]},{"name":"Pierre-Michel;LLORCA","email":"pmllorca@chu-clermontferrand.fr","type":"contact","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE CLERMONT-FERRAND","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/02tcf7a68","role":"organisation id","title":"ROR"},{"uri":"266307461","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"DNA"},{"keyword":"RNA"},{"keyword":"serum"},{"keyword":"toxoplasmosis"},{"keyword":"schizophrenia"},{"keyword":"monitoring"},{"keyword":"clinical"},{"keyword":"development"},{"keyword":"staging"},{"keyword":"biomarkers"},{"keyword":"biobank"},{"keyword":"neuropsychology"},{"keyword":"biology"},{"keyword":"vitamin D"}],"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":"Behavioral determinants: Addiction","vocab":"health determinant"},{"topic":"Socio-demographic and economic determinants","vocab":"health determinant"},{"topic":"Biological determinants: Genetic predisposition","vocab":"health determinant"},{"topic":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Behavioral determinants","vocab":"health determinant"},{"topic":"Behavioral determinants: Eating habits","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"}],"purpose":"The objective of the National Network of Schizophrenia Expert Centres is to offer diagnostic and therapeutic advice for patients with schizophrenic disorders and then monitor them for a period of three years. These patients will be thoroughly evaluated based on psychiatric (primary and related illnesses); psychological; somatic; cognitive and social assessment (impact of disease on functional outcome).","abstract":"","coll_dates":[{"start":"2009-01-01"}],"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            \"value\": \"Aged (65 to 79 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"All patients with schizophrenia and related disorders (schizophreniform or brief psychotic disorder) may participate in cohort monitoring, with no exclusion criteria. These disorders are effectively heterogeneous in nature, from clinical manifestations to illness progression and associated pathologies. The data from this cohort may be the only tool for studying the trajectory of the disease in the long term in accordance with different clinical profiles, differences in treatment and identifying aggravating factors. Due to the clinical heterogeneity of schizophrenia, given the characteristics of the disorder, but also the frequency of related somatic and psychiatric illnesses, it is important to monitor these cohorts in order to identify new treatment strategies and to follow-up specific target subgroups.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Participant-reported health data','Biological data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['All studies may be audited by the sponsor at any time. The investigator and his\/her team shall make themselves available during the auditor visits, as well as allowing auditors access to technical facilities, study material and patient records. Patient anonymity must be respected and information verified during these tests must remain confidential. 9.6. Quality control by health authorities. The following items may be checked during prospective inspections by the health authorities: \u2013 General organisation of the study \u2013 qualifications of the staff conducting the study \u2013 equipment quality \u2013 informed consent forms \u2013 CPP (Ethics Research Committee) approval \u2013 product delivery and storage methods \u2013 conduct of the study \u2013 archiving documentation related to the study. In the event of inspection by the authorities, the investigator shall notify the sponsor as the soon as the request is made.']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nHealth event\/mortality\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":""}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Converting or copying information into a structured record\"}"],"research_instrument":"Access on specific project only","sources":[{"sourceCitation":{"titlStmt":{"titl":""},"holdings":"","notes":{"subject":"source purpose","value":""}},"srcOrig":["Medico-administrative database"]}],"target_sample_size":"[1000-10000[ individuals","response_rate":"The network of centres is intended to be a permanent structure where the number of assessed individuals is not restricted."},"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":"Those with direct access in accordance with the laws and regulations in force, particularly Articles L.1121-3 and R.5121-13 of the Public Health Code (e.g. investigators, people in charge of quality control, monitors, clinical research assistants, auditors and all individuals duly authorised by the sponsor), shall take all necessary precautions to ensure the confidentiality of information related to experimental drugs, trials and participating individuals, particularly with regards to their identity and the results obtained. Data collected by these parties during quality control or auditing procedures shall be made anonymous.","conditions":"All requests from the public or private research body must be approved by the steering committee based on the submission of a project. 1. General Conditions. Access to clinical, neuropsychological and socioeconomic data, as well as biological samples, shall be possible for both private and public teams that participated in the creation of such collections and teams located in France or abroad. Requests for transferring data (clinical, neuropsychological or socioeconomic) and assigning biological samples will be validated by the scientific committee involved in the study, who will issue its decision based on: \u2013 the scientific relevance of the proposed study; \u2013 non-competition with research already begun by teams participating in creating the collection; \u2013 sample availability. It should be noted in this context that the requirements for obtaining available biological data by type and number shall differ from clinical, neuropsychological or socioeconomic data requirements. The ownership of results and potential terms of transfer (price, publications, etc.) will be drawn up in a contract. Samples will only be available by written request from the initiator throughout the duration of the study (Transfer Agreement). The Transfer Agreement authorises the release of certain samples according to specific conditions (recipient, transport cost, return of unused samples, publication requirements, etc.). All requests are approved in advance by the collection scientific committee, whose members include the head of the CRB in Mondor and the CRB in Piti\u00e9-Salp\u00eatri\u00e8re. Secondary use biological samples for research other than that initially planned is not possible without prior consent and following approval from the cohort scientific committee, as well as the establishment of a Transfer Agreement between the CRB. In the event of biomedical research organised by a public institution or private organisation, the use of human biological samples for research must involve drafting a Material Transfer Agreement (MTA); a contract that ensures the protection of intellectual property belonging to the Fondation FondaMental for research development and patent applications. 2. Access conditions for clinical data. The availability of clinical, neuropsychological or socioeconomic data will be finalised following approval by the steering committee. The requested items will be sent in the form of a database. 3. Access conditions for biological material. The availability of human biological materials kept at the biological resource centre (CRB) as part of the PSY-COHORTE SZ cohort will be finalised according to that set forth in the Research Collaboration Contract previously established between the Fondation FondaMental and heads from various organisations. The contract shall specify the beginning and end of the study; CRB obligations regarding the expected deliverables; guarantees regarding the quality and security of stored samples (preserving anonymity, monitoring temperature, etc.). The financial commitment terms should also be reiterated.","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":"10-10-2015","lastUpdatedAuto":null,"lastUpdatedManual":"03-07-2016","isContributorPI":"No","contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[{"type":"","title":"","link":"http:\/\/epidemiologie-france.aviesan.fr\/Metabolic syndrome, abdominal obesity and hyperuricemia in schizophrenia: Results from the FACE-SZ cohort. Godin O, Leboyer M, Gaman A, Aouizerate B, Berna F, Brunel L, Capdevielle D, Chereau I, Dorey JM, Dubertret C, Dubreucq J, Faget C, Gabayet F, Le Strat Y, Llorca PM, Misdrahi D, Rey R, Richieri R, Passerieux C, Schandrin A, Sch\u00fcrhoff F, Urbach M, Vidalhet P, Girerd N, Fond G; FACE-SZ group. Schizophr Res. 2015 Oct;168(1-2):388-94. doi: 10.1016\/j.schres.2015.07.047."}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Private non-profit"],"otherSponsorType":[""]},"governance":{"committee":"Yes"},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Yes","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"e-schizo(\u00a9) software application","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Yes"},"geographicalCoverage":{"geoDetail":"10 schizophrenia expert centres throughout the French territory (Bordeaux, Colombes, Cr\u00e9teil, Clermont-Ferrand, Lyon, Grenoble, Marseilles, Montpellier, Strasbourg, Versailles)"},"dataTypes":{"clinicalDataDetails":"General medical examination includes a complete psychiatric and somatic history (weight, BMI, waist circumference, blood pressure lying down, heart rate lying down, ECG). Heteroquestionnaire on mood and suicidal tendencies: \u2013 CDSS (depressive symptoms) \u2013 YMRS (manic symptoms) \u2013 SIS (suicidal thoughts) - Columbia (suicidal intentionality\/lethality) \u2013 PANSS (Positive and Negative Syndrome Scale) \u2013 CDSS (Calgary Depression Scale) \u2013 BARS (Brief Adherence Rating Scale) \u2013 SUMD (Scale to Assess Unawareness in Mental Disorder) \u2013 AIMS \u2013 BAS \u2013 Extrapyramidal side effects causing violent behaviour. Heteroquestionnaire to assess the impact of the disease on functioning: \u2013 CGI (Clinical Global Impression) - EGF (Global Assessment of Functioning \u2013 PSP scale). Treatment: \u2013 Somatic and psychiatric treatment undertaken in the last 12 months (or lifetime during baseline visit) \u2013 Ongoing treatment: Self-administered questionnaires to assess current symptomatic disease status: \u2013 Fagerstr\u00f6m \u2013 Quality of Life \u2013 AQ (Buss-Perry) \u2013 MARS (Medication Adherence Rating Scale) \u2013 Birchwood \u2013 BCIS \u2013 EQ-5D-5L \u2013 STORI \u2013 PSQI (sleep quality) \u2013 SOG (South Oaks Gambling Screen) \u2013 PIUQ-12 \u2013 Physical exercise III. Assessments carried out at baseline visit and every two years: \u2013 Neuropsychological tests: \u2013 Abbreviated WAIS IV \u2013 TAP (Test of Attentional Performance) \u2013 Edinburgh Handedness Inventory (Edinburgh) -\u2013 CVLT \u2013 CPT-IP \u2013 Six Elements Test \u2013 f-NART \u2013 Doors Test \u2013 TMT A et B \u2013 verbal fluency \u2013 SSTICS \u2013 Self-administered questionnaire: \u2013 Sociodemographic questionnaire parts I and II.","biologicalDataDetails":"Biochemical tests (sodium, potassium, chloride, urea, uric acid, creatinine clearance, iron, C-reactive protein, bilirubin, albumin, fasting blood sugar). Lipid profile (total cholesterol, HDL, LDL, triglycerides). Liver function tests (alkaline phosphatase, AST\/TGO, ALT\/TGP, gamma-GT). Thyroid function tests (TSH, ultrasensitive). FBC tests (leukocytes, erythrocytes, haemoglobin, haematocrit, neutrophils, MCV, platelets). Plasma hCG (only for women of childbearing age). Prolactin levels. Glycated haemoglobin if blood sugar level is >1.26 g\/dL; toxoplasma serology; vitamin D dosage.","isDataInBiobank":"Yes","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[""]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}