ITMO public health
Last update : 07/22/2014 | Version : 1 | ID : 5262
| General | |
| Identification | |
| Detailed name | Severe Drug Allergy Physiopathology and Characterisation of Novel Diagnostic and Therapeutic Targets |
| Sign or acronym | SAM |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | -- |
| General Aspects | |
| Medical area |
Study of allergies |
| Health determinants |
Genetic |
| Scientific investigator(s) (Contact) | |
| Name of the director | Nicolas |
| Surname | Jean-François |
| Address | Inserm Unité 111 - CIRI - 21 avenue Tony Garnier - 69007 Lyon |
| Phone | +33 (0)4 37 28 23 48 |
| jean-francois.nicolas@chu-lyon.fr | |
| Unit | Equipe 14 Inserm U1111- CIRI "Immunologie de l'allergie cutanée et vaccination" |
| Organization | INSERM - Institut National de la Santé et de la Recherche |
| Name of the director | Berard |
| Surname | Frédéric |
| Collaborations | |
| Funding | |
| Funding status |
Mixed |
| Details | AO HCL Action incitative 2009 INSERM/DHOS 2009 |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | INSERM - Institut National de la Santé et de la Recherche Médicale |
| Organisation status |
Public |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Longitudinal study (except cohorts) |
| 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 |
| Additional information regarding sample selection. | Prospective. All patients who attended CCR2A and agreed to be included in cohort. No randomisation or selection. |
| Database objective | |
| Main objective | To improve pathophysiological understanding of cutaneous Adverse Drug Reaction (cADRs) by clarifying the number and functional status of T lymphocytes (LT) CD8 + CTLs specific to medication. We wish to: i) confirm the involvement of CD8+ cells for different diseases; ii) understand why the same cell (CD8+) is responsible for different clinical forms of severity. |
| Inclusion criteria | Patient presenting with maculopapular rash (MPR), Drug Hypersensitivity Syndrome (DRESS) or Lyell's Syndrome (toxic epidermal necrolysis) (SJS/TEN) caused by medication, diagnosed by referring physicians in the Rhône-Alpes Auvergne Centre de Compétences (CCR2A) |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
Regional |
| French regions covered by the database |
Auvergne Rhône-Alpes |
| Detail of the geography area | Rhône-Alpes-Auvergne |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2009 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 102 |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Presence of a biobank |
Yes |
| Contents of biobank |
Whole blood Serum Blood cells isolated Fluids (saliva, urine, amniotic fluid, …) Tissues Others |
| Details of biobank content | Blood sample (30 mL heparin tube), Two skin biopsies (3 mm in diameter), one for damaged skin and one for healthy skin |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services |
| Care consumption (detail) |
Hospitalization Medical/paramedical consultation Medicines consumption |
| Procedures | |
| Data collection method | All cohort samples were collected by Allergobiotec (Headed up by Dr. Aurore Rozieres, INSERM U1111-CIRI/HCL). |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Systematic visit 3 months following reaction. Other follow-ups (6 months and 9 months) may be scheduled depending on the patient's condition and severity of reaction. A visit at 1 year is also systematic. |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Data from this cohort are accessible through scientific publications. If other researchers wish to access this data, a request must be made and data will be made available according to good clinical practice. Filtered "access request". No "open access". |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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