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

NCT ID: NCT06387654

Last Updated: 2024-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-06

Study Completion Date

2034-04-30

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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

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

Blood sampling

Intervention Type BIOLOGICAL

Blood will be taken in larger quantity

Remainders of samples taken as part of the treatment

Intervention Type BIOLOGICAL

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

Interventions

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Blood sampling

Blood will be taken in larger quantity

Intervention Type BIOLOGICAL

Remainders of samples taken as part of the treatment

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chloé BOST, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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University Hospital

Toulouse, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Chloé BOST, MD, PhD

Role: CONTACT

5 61 77 61 44 ext. 0033

Facility Contacts

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Chloé BOST, MD, PhD

Role: primary

5 61 77 61 44 ext. 0033

Other Identifiers

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RC31/23/0361

Identifier Type: -

Identifier Source: org_study_id

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