CARMEN - AUTOIMMUNE CYTOPENIA REGISTRY IN MIDI-PYRENEÉS REGION
Head :
Moulis Guillaume, UMR INSERM-Université de Toulouse 1027, équipe 6
Adoue Daniel
Adoue Daniel
Last update : 11/10/2017 | Version : 1 | ID : 5294
| General | |
| Identification | |
| Detailed name | AUTOIMMUNE CYTOPENIA REGISTRY IN MIDI-PYRENEÉS REGION |
| Sign or acronym | CARMEN |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL no. 2012-438; CCTIRS no. 12.067 |
| General Aspects | |
| Medical area |
Hematology Immunology |
| Pathology (details) | immune thromboctyopenia, autoimmune hemolytic anemia |
| Health determinants |
Iatrogenic Medicine |
| Keywords | immune thromboctyopenia, autoimmune hemolytic anemia, registry, epidemiology, pharmacoepidemiology |
| Scientific investigator(s) (Contact) | |
| Name of the director | Moulis |
| Surname | Guillaume |
| Address | Faculté de Médecine, 37 allées Jules Guesde 31000 Toulouse |
| Phone | + 33 (0)5 61 77 96 78 |
| moulis.g@chu-toulouse.fr | |
| Unit | UMR INSERM-Université de Toulouse 1027, équipe 6 |
| Organization | INSERM - Institut National de la Santé et de la Recherche |
| Name of the director | Adoue |
| Surname | Daniel |
| adoue.d@chu-toulouse.fr | |
| Collaborations | |
| Participation in projects, networks and consortia |
Yes |
| Details | MaRIH |
| Funding | |
| Funding status |
Mixed |
| Details | Toulouse university hospital, French Society of internal medicine, CSL Behring, Novartis |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Toulouse university hospital |
| Organisation status |
Public |
| Sponsor(s) or organisation(s) responsible | INSERM - Institut National de la Santé et de la Recherche Médicale |
| Organisation status |
Public |
| Presence of scientific or steering committees |
Yes |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Morbidity registers |
| Additional information regarding sample selection. | Investigators prospectively include all newly diagnosed adult patients for ITP of AIHA |
| Database objective | |
| Main objective | To describe the epidemiology of immune thrombocytopenic purpura (ITP) and of autoimmune hemolytic anemia (AIHA) , real-life exposure to treatments and their risk-benefit ratio. |
| Inclusion criteria |
- aged 18 or over
- outvisit or hospitalisation for ITP or AIHA diagnosis - no oppsition to participate - followed in the Midi-Pyrénées region |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) Great age (80 years and more) |
| Population covered |
Sick population |
| Pathology | D69 - Purpura and other haemorrhagic conditions |
| D59 - Acquired haemolytic anaemia | |
| Gender |
Male Woman |
| Geography area |
Regional |
| French regions covered by the database |
Languedoc-Roussillon Midi-Pyrénées |
| Detail of the geography area | Midi-Pyrénées (Occitanie West) |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2013 |
| Date of last collection (YYYY or MM/YYYY) | 2023 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 298 at december 31,2016 |
| 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) | At diagnosis and during follow up if any event occurs |
| Biological data (detail) | At diagnosis and during follow up |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services Quality of life/health perception |
| Care consumption (detail) |
Hospitalization Medical/paramedical consultation Medicines consumption |
| Procedures | |
| Data collection method | Follow-up forms will be completed by the investigating physician upon each patient consultation or hospitalisation at the investigating centre |
| Quality procedure(s) used | Check of data by medical record review by Reserch Assistant and medicine doctor specilized in autoimmune cytopenia if necessary |
| Participant monitoring |
Yes |
| Monitoring procedures |
Monitoring by contact with the referring doctor |
| Details on monitoring of participants | 10 years |
| Links to administrative sources |
Yes |
| Linked administrative sources (detail) | SNIIR-AM for completeness assessment |
| Promotion and access | |
| Promotion | |
| Link to the document | published_article.pdf |
| Description | Study protocol |
| Link to the document | Moulis_et_al-2017-American_Journal_of_Hematology.pdf |
| Description | Epidemiology of ITP |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) |
Consult person in charge.
registre.carmen@chu-toulouse.fr for all operational information. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
