Clinical trial NCT06387654: Clinico-biological Collection of Autoimmune, Dysimmune or Auto-inflammatory Dermatological Diseases
Official title: Constitution of a Collection of Biological Samples With the Aim of Carrying Out Clinico-biological and Physiopathological Investigations of Autoimmune, Dysimmune or Auto-inflammatory Dermatological Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 800
Sex: ALL
Minimum age (years): 6
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with autoimmune, dysimmune or auto-inflammatory dermatological disease

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.

Detailed description: Autoimmune diseases include around a hundred different clinical entities which are for the most part rare pathologies but which, in combination, concern 5-8% of the adult population with a strong female predominance (FAI²R: the disease chain rare autoimmune and auto-inflammatory drugs, fai2r.org). The common denominator of all these diseases is based on the breakdown of self-tolerance which is the origin of self-reactivity and whose physiopathological mechanisms are still not fully understood, which generates numerous cross-sectional or fundamental studies. In addition to this complexity, there are significant inter-individual variabilities which lead to the definition of subgroups of patients on the basis of the clinical-biological profile and / or the response to treatments. Consequently, and in view of the need to establish the diagnosis early and then to propose the best treatment in the perspective of an individualized medicine, the clinical, biological and genetic characteristics of these subgroups of patients must be explored in order to improve diagnostic and therapeutic capacities.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Building a collection of biological samples and clinical-biological data from patients with autoimmune, dysimmune or auto-inflammatory dermatological disease
timeFrame: Day 0 and through study completion, an average of 1 year
Secondary outcomes:
measure: Identification of new autoantibodies
timeFrame: Day 0 and through study completion, an average of 1 year
measure: Identification of biomarkers regarding the severity (such as cytokines, survival factors) in order to help the therapeutic decisions
timeFrame: Day 0 and through study completion, an average of 1 year
measure: Exploration of the pathophysiological mechanisms of rare autoimmune dermatological pathologies
timeFrame: Day 0 and through study completion, an average of 1 year
measure: Comparison of blood cells populations determinants with flow cytometry, before and after cell therapy and in patients responder or not responder to cell therapy
timeFrame: Day 0 and through study completion, an average of 1 year
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital
Study officials:
affiliation: University Hospital, Toulouse
name: Chloé BOST, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: