Clinico-biological Collection of Autoimmune, Dysimmune or Auto-inflammatory Dermatological Diseases

NCT06387654 | Recruiting

• 1 other identifier: RC31/23/0361
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this project is to start a biological and clinical collection of patients presenting autoimmune, dysimmune or auto-inflammatory dermatological diseases. This collection will provide appropriate biological samples to identify new biomarkers and to be accessible to the medical, scientific and industrial communities for the identification of new therapeutic strategies.

Conditions

Autoimmune Bullous Dermatosis; Dysimmune Dermatological Diseases; Auto-inflammatory Dermatological Diseases; Skin Diseases

Keywords

auto-inflammatory dermatological diseases; Cutaneous lupus; scleroderma; dermatomyositis; psoriasis; eczema; new therapies

Outcome Measures

Primary Outcomes (1)

• Building a collection of biological samples and clinical-biological data from patients with autoimmune, dysimmune or auto-inflammatory dermatological disease

  Blood sampling

  Day 0 and through study completion, an average of 1 year

Secondary Outcomes (4)

• Identification of new autoantibodies

  Day 0 and through study completion, an average of 1 year

• Identification of biomarkers regarding the severity (such as cytokines, survival factors) in order to help the therapeutic decisions

  Day 0 and through study completion, an average of 1 year

• Exploration of the pathophysiological mechanisms of rare autoimmune dermatological pathologies

  Day 0 and through study completion, an average of 1 year

• Comparison of blood cells populations determinants with flow cytometry, before and after cell therapy and in patients responder or not responder to cell therapy

  Day 0 and through study completion, an average of 1 year

Study Arms (1)

Patients suffering from autoimmune, dysimmune or auto-inflammatory dermatological disease

Biological samples will be collected in the normal diagnosis and follow-up process

Biological: Blood sampling; Biological: Remainders of samples taken as part of the treatment

Interventions

Blood sampling BIOLOGICAL

Blood will be taken in larger quantity

Patients suffering from autoimmune, dysimmune or auto-inflammatory dermatological disease

Remainders of samples taken as part of the treatment BIOLOGICAL

blood, CSF, saliva, stools, urine, other biological fluids and tissue biopsies, hair follicles

Patients suffering from autoimmune, dysimmune or auto-inflammatory dermatological disease

Eligibility Criteria

• Age: 6 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with autoimmune, dysimmune or auto-inflammatory dermatological disease

You may qualify if:

• Skin damage of documented or probable autoimmune, dysimmune or autoinflammatory origin.
• The patients included may be adults or children, and will be:
• Patients with autoimmune bullous dermatoses (pemphigus, pemphigoid and others),
• Patients with systemic autoimmune diseases associated with skin damage (lupus, scleroderma, dermatomyositis for example),
• Patients with cutaneous lupus
• Patients with dysimmune skin diseases (psoriasis, eczema)
• Patients with immuno-induced dermatological disorders or drug dermatitis
• Patients receiving, or likely to receive, new, innovative therapies (new molecule on the market, checkpoint inhibitors, gene therapy, cell therapy, etc.).
• Patients with dermatological damage whose autoimmune, dysimmune or auto-inflammatory origin is suspected

You may not qualify if:

• Patients under protective supervision (guardianship, curators)
• Patients under 6 years old
• Pregnant or breastfeeding woman

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital

Toulouse, 31059, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood, CSF, saliva, stool, urine, other body fluids and tissue biopsies, hair follicles

MeSH Terms

Conditions

Skin Diseases; Scleroderma, Diffuse; Dermatomyositis; Psoriasis; Eczema

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases; Scleroderma, Systemic; Connective Tissue Diseases; Polymyositis; Myositis; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Skin Diseases, Papulosquamous; Dermatitis; Skin Diseases, Eczematous

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Chloé BOST, MD, PhD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chloé BOST, MD, PhD

CONTACT

5 61 77 61 44; bost.c@chu-toulouse.fr

Study Design

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

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 29, 2024
• Study Start: May 6, 2024
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2034
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)