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Clinico-biological Collection to Investigate the Physiopathology of Systemic Autoimmune Diseases

Constitution of a Collection of Biological Samples With the Aim of Carrying Out Clinico-biological and Pathophysiological Investigations of Systemic Autoimmune Diseases

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05251415
Acronym
ESSAi
Enrollment
3000
Registered
2022-02-22
Start date
2022-04-04
Completion date
2032-04-04
Last updated
2026-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Diseases, Lupus Erythematosus, Myositis, Scleroderma, Vasculitis

Keywords

systemic autoimmune diseases, scleroderma, lupus, myositis, vasculitis, Inflammatory Bowel Diseases, new therapies

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.

Interventions

BIOLOGICALBlood sampling

Blood will be taken in larger quantity.

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Constitution of a collection of biological samples and clinical-biological data from patients with autoimmune diseasesthrough study completion, an average of 1 yearProspective collection of all available biological samples and clinical data collected during the normal clinical care

Secondary

MeasureTime frameDescription
Identification and / or validation of new biomarkers for diagnostic and / or prognostic purposesthrough study completion, an average of 1 yearUse of immune cells and / or biological liquids obtained from patients for cohort studies with new methods of screening (microarray, flow cytometry)
Identification and / or validation of new predictive biomarkers of relapse and / or response to treatmentthrough study completion, an average of 1 yearUse of immune cells and / or biological liquids obtained from patients for cohort studies with new methods of screening (microarray, flow cytometry)
Identification of specificities in these patients in order to improve the diagnosis, treatment decisions and / or the pathophysiological understanding of these diseasesthrough study completion, an average of 1 yearUse of immune cells and / or biological samples for transcriptomic and / or proteomic studies, or in order to be used in experimental animal models
Identification of the determinants of immune reconstitution after cell therapythrough study completion, an average of 1 yearExploring blood cell populations before and after cell therapy with flow cytometry

Countries

France

Contacts

CONTACTChloé BOST, MD, PhD
bost.c@chu-toulouse.fr5 61 77 61 44
PRINCIPAL_INVESTIGATORChloé BOST, MD, PhD

University Hospital, Toulouse

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026