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

Skin Diseases Clinical Trial

— TekAPo  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06387654
• Other study ID #: RC31/23/0361
• Status: Recruiting
• Start date: May 6, 2024
• Est. completion date: April 2034

Study information

• Verified date: May 2024
• Source: University Hospital, Toulouse
• Contact: Chloé BOST, MD, PhD
• Phone: 5 61 77 61 44
• Email: bost.c[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: April 2034
• Est. primary completion date: April 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Skin Diseases

Intervention

Biological:
• Blood sampling
Blood will be taken in larger quantity
• Remainders of samples taken as part of the treatment
blood, CSF, saliva, stools, urine, other biological fluids and tissue biopsies, hair follicles

Locations

Country	Name	City	State
France	University Hospital	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Identification of new autoantibodies	Western blot or immunoprecipitation method	Day 0 and through study completion, an average of 1 year
Secondary	Identification of biomarkers regarding the severity (such as cytokines, survival factors) in order to help the therapeutic decisions	Proteomic analysis of sera and plasma samples at diagnosis and during follow up	Day 0 and through study completion, an average of 1 year
Secondary	Exploration of the pathophysiological mechanisms of rare autoimmune dermatological pathologies	Knock-out or knock-in animal models for one specific protein will be used to determine in vivo if the pathophysiological mechanisms of Dermatological Diseases can be induced by the abnormal expression of this protein.; Analysis of the phenotypic profiling of blood immune cells by multicolor fluorescence-activated cell sorter (FACS) analysis and of the transcriptomic profiling of blood immune cells by RNA sequencing	Day 0 and through study completion, an average of 1 year
Secondary	Comparison of blood cells populations determinants with flow cytometry, before and after cell therapy and in patients responder or not responder to cell therapy	Exploring blood cell populations before and after cell therapy with flow cytometry	Day 0 and through study completion, an average of 1 year