Clinical trial NCT05251415: Clinico-biological Collection to Investigate the Physiopathology of Systemic Autoimmune Diseases
Official title: Constitution of a Collection of Biological Samples With the Aim of Carrying Out Clinico-biological and Pathophysiological Investigations of Systemic Autoimmune Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lupus Erythematosus
Scleroderma
Myositis
Vasculitis
Inflammatory Bowel Diseases
Keywords: systemic autoimmune diseases
scleroderma
lupus
myositis
vasculitis
Inflammatory Bowel Diseases
new therapies
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2022-02-22
Enrollment: 3000
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 diseases

Brief summary: The aim of this project is to start a biological and clinical collection of patients presenting systemic autoimmune disease. 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 group together less than 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:

* Patients with rare systemic autoimmune diseases (lupus, scleroderma, myositis for example),
* Patients with atypical presentations of documented or probable systemic autoimmune diseases,
* Patients receiving, or likely to receive new, innovative therapies (new molecule on the market, gene therapy, cell therapy, etc.).

Exclusion Criteria:

* Known anemia and hemoglobin \<10 g / dl
* Patients under protective supervision (guardianship, curators)
* Pregnant or breastfeeding woman

Primary outcomes:
measure: Constitution of a collection of biological samples and clinical-biological data from patients with autoimmune diseases
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Identification and / or validation of new biomarkers for diagnostic and / or prognostic purposes
timeFrame: through study completion, an average of 1 year
measure: Identification and / or validation of new predictive biomarkers of relapse and / or response to treatment
timeFrame: through study completion, an average of 1 year
measure: Identification of specificities in these patients in order to improve the diagnosis, treatment decisions and / or the pathophysiological understanding of these diseases
timeFrame: through study completion, an average of 1 year
measure: Identification of the determinants of immune reconstitution after cell therapy
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Purpan University Hospital
Study officials:
affiliation: University Hospital, Toulouse
name: Chloé BOST, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: