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NCT Number: NCT05251415

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sampling

Biological

Blood will be taken in larger quantity.

Primary outcomes

  1. Constitution of a collection of biological samples and clinical-biological data from patients with autoimmune diseases

    Time frame: through study completion, an average of 1 year

    Prospective collection of all available biological samples and clinical data collected during the normal clinical care

Secondary outcomes

  1. Identification and / or validation of new biomarkers for diagnostic and / or prognostic purposes

    Time frame: through study completion, an average of 1 year

    Use of immune cells and / or biological liquids obtained from patients for cohort studies with new methods of screening (microarray, flow cytometry)

  2. Identification and / or validation of new predictive biomarkers of relapse and / or response to treatment

    Time frame: through study completion, an average of 1 year

    Use of immune cells and / or biological liquids obtained from patients for cohort studies with new methods of screening (microarray, flow cytometry)

  3. Identification of specificities in these patients in order to improve the diagnosis, treatment decisions and / or the pathophysiological understanding of these diseases

    Time frame: through study completion, an average of 1 year

    Use of immune cells and / or biological samples for transcriptomic and / or proteomic studies, or in order to be used in experimental animal models

  4. Identification of the determinants of immune reconstitution after cell therapy

    Time frame: through study completion, an average of 1 year

    Exploring blood cell populations before and after cell therapy with flow cytometry

Study contacts

Contact information is provided by the study sponsor or research team.

Chloé BOST, MD, PhD

CONTACT

[email protected]

5 61 77 61 44 ext. 0033

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: ESSAi

Important dates

Study start
2022
Primary completion
2027
Study completion
2032
First posted
Feb 22, 2022
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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