Drug Reactions Sampling (COLLECTIONTOXIDERMIES)
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|ClinicalTrials.gov Identifier: NCT03659227|
Recruitment Status : Recruiting
First Posted : September 6, 2018
Last Update Posted : January 22, 2019
Intro: Dermatology department of Henri Mondor Hospital (Creteil, France), is a reference center for toxic bullous diseases and severe cutaneous drug reactions (Stevens-Johnson syndrome (SJS), Lyell syndrome (toxic epidermal necrolysis (TEN)), generalized bullous fixed drug reactions, AGEP, DRESS, drug induced immunoglobulin A (IgA) bullous dermatosis, and erythema multiforme). In order to conduct clinical and biological research studies in drug reactions, it is necessary for the investigator's department to implement a collection of clinical data and biological samples.
Hypothesis/Objective: To collect clinical data and cutaneous and biological samples for immunological, biological and genetic studies to improve knowledge about pathophysiology of drug reactions.
Method: The following samples will be performed in addition to the routine practice samples: one skin punch biopsy (6mm); 43 mL of blood; blister fluid aspiration; oral and nose mucous membrane and skin eSWABs, stool samples.
These samples will be stored in a dedicated biological sampling department ("Platform of biological resources").
Conclusion: The implementation of this collection should allow us to conduct pathophysiological studies about drug reactions.
|Condition or disease|
|Stevens-Johnson Syndrome Lyell Syndrome Drug Reactions AGEP DRESS Bullous Dermatosis Caused by Drug Treatment (Disorder) Maculopapular Exanthem Erythema Multiforme|
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Adverse Cutaneous Drug Reactions Collection of Clinical Data and Biological Samples|
|Actual Study Start Date :||September 26, 2018|
|Estimated Primary Completion Date :||September 25, 2023|
|Estimated Study Completion Date :||September 25, 2028|
- Implementation of a clinical data and biological samples collection for cutaneous adverse reactions [ Time Frame: Day 0 ]Implementation of a clinical data and biological samples collection for cutaneous adverse reactions
- To conduct clinical and biological (immunological, histological, microbiological and genetic) studies in cutaneous adverse reactions. [ Time Frame: Day 0 ]To conduct clinical and biological (immunological, histological, microbiological and genetic) studies in cutaneous adverse reactions.
Biospecimen Retention: Samples With DNA
- one skin punch biopsy
- blood (serum, cells, DNA and RNA studies);
- blister fluid aspiration;
- oral and nose mucous membrane and skin eSWABs ;
- stool samples.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03659227
|Contact: Saskia Oro, MD||0149812536 ext +email@example.com|
|Contact: Laetitia Gregoire||0149814164 ext +firstname.lastname@example.org|
|Créteil, France, 94010|
|Contact: Saskia Oro, MD|
|Principal Investigator:||Saskia Oro, MD||APHP|