Drug Reactions Sampling (COLLECTIONTOXIDERMIES)

NCT03659227 | Recruiting DMC

• 1 other identifier: K180201J
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stevens-Johnson Syndrome; Lyell Syndrome; Drug Reactions; AGEP; DRESS; Bullous Dermatosis Caused by Drug Treatment (Disorder); Maculopapular Exanthem; Erythema Multiforme

Keywords

Drug reactions; severe cutaneous adverse reactions (SCARs; Stevens-Johnson syndrome; Lyell Syndrome; (generalized bullous) fixed drug reaction; AGEP; DRESS; drug induced IgA bullous dermatosis; maculopapular exanthema; erythema multiforme; sampling; collection

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• To conduct clinical and biological (immunological, histological, microbiological and genetic) studies in cutaneous adverse reactions.

  Day 0

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Patient ≥ 18 y-old
• Severe cutaneous drug reaction (AGEP, DRESS, SJS/TEN, generalized bullous fixed drug eruption), drug-induced IgA bullous dermatosis, maculopapular exanthema, erythema multiforme
• Signed consent
• Social security affiliation

You may not qualify if:

• Patients law protection

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Henri Mondor

Créteil, 94010, France

RECRUITING

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.

MeSH Terms

Conditions

Stevens-Johnson Syndrome; Drug-Related Side Effects and Adverse Reactions; Drug Eruptions; Erythema Multiforme; Cicatrix

Condition Hierarchy (Ancestors)

Stomatitis; Mouth Diseases; Stomatognathic Diseases; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Erythema; Skin Diseases, Vesiculobullous; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Drug Hypersensitivity; Chemically-Induced Disorders; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Saskia Oro, MD

  APHP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saskia Oro, MD

CONTACT

0149812536; saskia.oro@aphp.fr

Laetitia Gregoire

CONTACT

0149814164; laetitia.gregoire@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2018
• First Posted: September 6, 2018
• Study Start: September 26, 2018
• Primary Completion: September 25, 2023
• Study Completion (Estimated): September 25, 2028
• Last Updated: May 3, 2022

Record last verified: 2022-04

Locations

FR (1)