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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Implementation of a clinical data and biological samples collection for cutaneous adverse reactions | Implementation of a clinical data and biological samples collection for cutaneous adverse reactions | Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| To conduct clinical and biological (immunological, histological, microbiological and genetic) studies in cutaneous adverse reactions. | To conduct clinical and biological (immunological, histological, microbiological and genetic) studies in cutaneous adverse reactions. | Day 0 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with severe cutaneous adverse reactions (DRESS, AGEP, SJS/TEN, generalized bullous fixed drug eruption), drug-induced IgA linear dermatosis, maculo-papular exanthema, erythema multiforme.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Saskia Oro, MD | Contact | 0149812536 | +33 | saskia.oro@aphp.fr |
| Laetitia Gregoire | Contact | 0149814164 | +33 | laetitia.gregoire@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Saskia Oro, MD | APHP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henri Mondor | Recruiting | Créteil | 94010 | France |
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| ID | Term |
|---|---|
| D013262 | Stevens-Johnson Syndrome |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D003875 | Drug Eruptions |
| D004892 | Erythema Multiforme |
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D013280 | Stomatitis |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D003872 | Dermatitis |
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| D012871 |
| Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004890 | Erythema |
| D012872 | Skin Diseases, Vesiculobullous |
| D006968 | Hypersensitivity, Delayed |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D004342 | Drug Hypersensitivity |
| D064419 | Chemically-Induced Disorders |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |