ITMO public health
Last update : 03/01/2012 | Version : 1 | ID : 3145
| General | |
| Identification | |
| Detailed name | French Cohort of Three Major Psychiatric disorders: Schizophrenia, Bipolar disorders, and Asperger syndrome |
| Sign or acronym | Psy-COH |
| General Aspects | |
| Medical area |
Psychology and psychiatry |
| Health determinants |
Addictions Genetic Geography Social and psychosocial factors |
| Others (details) | Schizophrenia, Bipolar disorders, ans Asperger syndrome |
| Scientific investigator(s) (Contact) | |
| Name of the director | Leboyer |
| Surname | Marion |
| marion.leboyer@inserm.fr | |
| Organization | Fondation FondaMental - UPEC - Inserm |
| Collaborations | |
| Funding | |
| Funding status |
Mixed |
| Details | ANR "Investissements d'avenir", Sanofi |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Fondation FondaMental |
| Organisation status |
Private |
| Sponsor(s) or organisation(s) responsible | Université Paris-est-Créteil (UPEC) - Université Pierre et Marie Curie (UPMC) |
| Organisation status |
Public |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Cohort study |
| Database recruitment is carried out by an intermediary |
A selection of health institutions and services |
| Database recruitment is carried out as part of an interventional study |
No |
| Database objective | |
| Main objective |
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. |
| Inclusion criteria | 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) |
| Population type | |
| Age |
Adolescence (13 to 18 years) Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | Patients will be recruited in the expert centers involved in the french network. This network is composed of 8 bipolar disorders (Bordeaux, Créteil, Grenoble, Marseille, Montpellier, Paris, Strasbourg, Versailles), 8 for schizophrenia (Clermont-Ferrand, Créteil, Lyon, Marseille, Montpellier, Paris, Strasbourg, Versailles) and 4 for Asperger syndrome (Bordeaux, Créteil, Paris, Toulouse) |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2012 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | We aim to recruit 1000 bipolar, 800 schizophrenic, and 200 Asperger patients. |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Declarative data Paraclinical data Biological data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Declarative data (detail) |
Paper self-questionnaire |
| Paraclinical data (detail) | Brain imaging |
| Biological data (detail) | 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, ... |
| Presence of a biobank |
Yes |
| Contents of biobank |
Whole blood Serum Plasma DNA DNAc/RNAm |
| Details of biobank content | The collections will be constituted of different bio-samples all derived from blood: DNA for genetic and epigenetic studies, RNA and lymphocytes for transcriptomics, serum for proteomics and metabolomics analyses. Blood sampling will be performed first at inclusion for each of the 2000 expected subjects, and then on a yearly basis during the clinical follow-up. On the contrary to others specimen, lymphoblastoid cell lines will be established only once at first inclusion. Blood will be collected in tubes supplemented with EDTA for DNA extraction, with lithium heparin for lymphocyte isolation, in silicone costed for serum and in PAXgene collection tubes for RNA extraction |
| Health parameters studied |
Health event/morbidity Health care consumption and services Quality of life/health perception |
| Care consumption (detail) |
Hospitalization Medical/paramedical consultation Medicines consumption |
| Procedures | |
| Data collection method | 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. |
| Participant monitoring |
Yes |
| Details on monitoring of participants | We plan to follow-up during ten years the impact of environemental factors (such as stress, migration, urban condition, cannabis), and to use innovative medical devices to examine objective parameters that might be associated with risk and relapse such as indicators of circadian rhythm (actimetry, web based diary, as well as body monitor), but also indicators of somatic disorders (weight, biological tests...). Blood sampling will be performed every year to follow up native DNA and RNA to explore the possible changes of epigenetic markers during follow-up as well as immuno-inflammation parameters measured in serum |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.fondation-fondamental.org/ |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Psy-COH will allow data access to academic as well as industrial partners, thus giving birth to numerous innotiative projects |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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