{"doc_desc":{"title":"French Cohort of People with Schizophrenia: Assessment of Different Stages of Illness Severity and Recovery","idno":"FRESH-PEF73247-en","producers":[{"name":"Guillaume FOND","affiliation":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73247-en","IDno":{"metadata_no":[{"agency":"PEF","code":"73247"},{"agency":"FReSH","code":"FRESH-PEF73247"}]},"title":"French Cohort of People with Schizophrenia: Assessment of Different Stages of Illness Severity and Recovery","alternate_title":"PSY-coh 2"},"study_authorization":{"agency":[]},"authoring_entity":[{"name":"Guillaume;FOND","firstname":"Guillaume","lastname":"FOND","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00pg5jh14","role":"organisation id"},{"title":"SIREN","uri":"267500452","role":"organisation id"}],"email":"guillaume.fond@gmail.com","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","PILabo":"Mondor University Hospital; AP-HP; DHU Pe-Psy; Cr\u00e9teil; Inserm U955 team 15, Fondation Fondamental","isContact":true},{"name":"Pierre-Michel;LLORCA","firstname":"Pierre-Michel","lastname":"LLORCA","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02tcf7a68","role":"organisation id"},{"title":"SIREN","uri":"266307461","role":"organisation id"}],"email":"pmllorca@chu-clermontferrand.fr","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE CLERMONT-FERRAND","PILabo":"Clermont-Ferrand University Hospital","isContact":true}],"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":"Guillaume;FOND","lastname":"FOND","firstname":"Guillaume","type":"contact","email":"guillaume.fond@gmail.com","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","lastname":"LLORCA","firstname":"Pierre-Michel","type":"contact","email":"pmllorca@chu-clermontferrand.fr","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":"rehabilitation"},{"keyword":"antipsychotic treatment response"},{"keyword":"health economics"},{"keyword":"vitamin D"},{"keyword":"compliance"},{"keyword":"staging"},{"keyword":"insight"},{"keyword":"adherence"},{"keyword":"inflammation"},{"keyword":"schizophrenia"},{"keyword":"comorbidity"},{"keyword":"progression"},{"keyword":"depression"},{"keyword":"suicide"},{"keyword":"employment"},{"keyword":"work"},{"keyword":"infection"}],"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":"Behavioral determinants: Addiction","vocab":"health determinant"},{"topic":"Socio-demographic and economic determinants","vocab":"health determinant"},{"topic":"Biological determinants: Genetic predisposition","vocab":"health determinant"},{"topic":"Environmental determinants: Other","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":"Environmental determinants","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"}],"purpose":"To identify the biomarkers for each stage as defined by the McGorry classification and characterised by clinical, therapeutic, biological, neuropsychological, environmental variables and living conditions.","abstract":"","coll_dates":[{"start":"2015-01-01","end":"2019-01-01"}],"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    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Subjects must meet the following conditions and characteristics to be included in the study:  1. Men and women meeting the schizophrenia DSM-IV criteria [American Psychiatric Association, 1994] presenting with the first episode of schizophrenia less than 10 years ago (the first episode is defined as the date the first antipsychotic was prescribed for a psychotic disorder by a physician, whether observed or not and, failing this, the date of the first psychotic episode characterised according to the criteria of the Structured Clinical Interview for DSM-IV Disorders Version 1 (SCID-1));  2. Who have given informed written consent (or given by both parents if the subject is a minor); 3. Patients who understand written and spoken French. .\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Participant-reported health data','Biological data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Research will be regulated according to sponsor standard operating procedures. Research conducted at investigation centres and management of subjects will be in accordance with the Declaration of Helsinki and existing good practices. 9.1 Monitoring procedures. The CRA representing the sponsor shall conduct investigation centre visits scheduled according to the patient follow-up scheme in the protocol, at baseline within the various centres and at the designated research risk level. \u2013 Initiation visit at each centre: before enrolment of patient in study in order to implement the protocol and familiarisation with the various biomedical research stakeholders. \u2013 Case report forms will be reviewed by the CRA as the research advances during subsequent visits. The investigators undertake to receive the CRA at regular intervals. The following items will be reviewed during on-site visits and in accordance with good clinical practice: Adherence to defined research protocol and procedures; verification of patient informed consent; review of source documents and comparison with data recorded in the case report form for accuracy, missing data and data consistency according to the rules set forth by the Fondation FondaMental procedures. The accuracy and consistency of the data exclusively filled out in eCRFs by the expert centres are directly verified on the FACE BD database by a data manager. Checks will be carried out at several levels: Validation of online entry; consistency check of entries followed by a more complex consistency control procedure, generating requests issued by the clinician. Audit trail; back-up and archiving of databases will be automated. \u2013 Final visit: Recovery of clinical report form; verification of research documents; archiving; verification of sample transfer to the centralised laboratory. Data directly entered in the eCRF will be verified on the database and archived on the server in an automated manner. 9.2 Definition of collected clinical data. All data contained in the clinical report form or entered online by the clinician are entered in the database managed by the Fondation FondaMental. 9.3 Description of data circuit before online entry. 9.3.1 Data from the expert centre clinical report form. All phenotypic, clinical, biochemical and neuropsychological data will be collected systematically and either collected in a clinical report form in the subject expert centre and then entered in an online e-CRF (bioinformatics manager from the Fondation FondaMental) or entered directly online by the clinician. 9.3.2 Data from the specific module (\u00a73.3.2.1). All data (environmental factors, health economics and quality of life) collected in the CIC will be reported in a specific form that will be sent to the coordinating expert centre and entered by a clinical research associate. 9.4 Electronic data entry. Database management and the generation of data files for conducting analyses will be carried out by the Fondation FondaMental IT team in accordance with the specifications sent by the coordinating centre. Data will either be collected through a web interface or sent directly to the Fondation FondaMental (for large-scale genotype files, for example). Clinical research forms will be completed by the clinician online or on paper, then followed-up and entered. Checks will be carried out at several levels: Validation of online entry; consistency check for entries followed by a more complex consistency control procedure; generating requests issued by the clinician. Audit trail; back-up and archiving of databases will be automated. All CRFs will be returned after being entered in the investigating departments. The generated variables (scale scores; sub-scores; variable combinations) will be dynamically published during analysis file creation. Electronic data on file will be declared to the CNIL. 9.5 Quality control by audit team. Studies may be audited by the sponsor at any time. The investigator and his\/her team shall make themselves available during auditor visits, as well as allowing auditors access technical facilities, study material and patient records. Patient anonymity must be respected and information verified during these tests shall 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 care consumption and services\r\nQuality of life\/health perception\r\nOthers"}]},"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\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Converting or copying information into a structured record\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"< 500 individuals","response_rate":"400"},"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":"Validation of cohort access requests 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. 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 COSED 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. 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.","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":"09-10-2015","lastUpdatedAuto":null,"lastUpdatedManual":"03-07-2016","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Private non-profit"],"otherSponsorType":[""]},"governance":{"committee":true},"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":"e-schizo(\u00a9) electronic database","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"10 expert centres (Bordeaux Colombes Clermont-Ferrand Cr\u00e9teil Montpellier Marseilles Versailles Strasbourg Grenoble Lyon)"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"Two types of biological data: Data collected systematically by the expert centre as part of routine care and recorded in the case report form; these are managed centrally in the Biological Resource Centres. Biological data not managed centrally (routine monitoring carried out as part of expert centre care). This includes: Biochemical tests (sodium, potassium, chloride, urea, uric acid, creatinine clearance, iron, C-reactive protein, 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. Results will be recorded in the eBP electronic medical record. Centrally managed biological data (samples taken at the clinical investigation centres (CIC) for biobank creation). The individual tubes allow serum, plasma, peripheral blood mononuclear cells, DNA and RNA to be collected. These tubes will be split into a number of aliquots sufficient for carrying out various analyses to be explored in the near future. Description: Samples for extracting DNA, RNA, serum, plasma, peripheral blood mononuclear cells will be collected by the CIC or, failing this, the expert centres at the baseline visit and then every two years for the duration of the study.","isDataInBiobank":true,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}