SAM - Severe Drug Allergy Physiopathology and Characterisation of Novel Diagnostic and Therapeutic Targets

Head :
Nicolas Jean-François, Equipe 14 Inserm U1111- CIRI "Immunologie de l'allergie cutanée et vaccination"
Berard Frédéric

Last update : 07/22/2014 | Version : 1 | ID : 5262

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Métadonnées
Identification
General Aspects
Scientific investigator(s) (Contact)
Collaborations
Funding
Governance of the database
Additional contact
Type of database
Database objective
Population type
Dates
Size of the database
Data
Procedures
Promotion
Access
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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
Email 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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