ClinicalTrials.gg
RecruitingNCT05251415ESSAiUpdated Mar 17, 2026

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

An observational study in Lupus Erythematosus, Scleroderma and Myositis, sponsored by University Hospital, Toulouse. Recruiting at 1 site in France. Open to participants aged 6 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-03-17.

Sponsored by University Hospital, Toulouse · Observational

From the registry’s dates

  • Started Apr 2022; still recruiting 4 years 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3,000
Ages
6 Years to 99 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

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

Keywords

  • systemic autoimmune diseases
  • scleroderma
  • lupus
  • myositis
  • vasculitis
  • Inflammatory Bowel Diseases
  • new therapies
03

In context

Scleroderma, Diffuse

310 studies on the registry are indexed under Scleroderma, Diffuse; 76 are open to participants now.

This study's planned enrollment of 3,000 is above the median of 113 across 68 observational studies indexed under Scleroderma, Diffuse.

Browse Scleroderma, Diffuse studies →

Lead sponsor

University Hospital, Toulouse is the lead sponsor of 807 studies on the registry; 209 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with autoimmune diseases

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with rare systemic 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

Exclusion Criteria:

  • Known anemia and \<10 g / dl
  • Patients under protective supervision (guardianship, curators)
  • Pregnant or breastfeeding woman
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • patients suffering from autoimmune disease

    Biological samples will be collected in the normal diagnosis and follow-up process. Only blood will be taken in larger quantity.

    Biological: Blood sampling

Interventions

  • BiologicalBlood sampling

    Blood will be taken in larger quantity.

06

What researchers measure

Primary outcomes

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

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

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

Secondary outcomes

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

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

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

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

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

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

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

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

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

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

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

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05251415
Responsible party
Sponsor
First posted
Feb 22, 2022
Start date
Apr 4, 2022
Primary completion
Apr 4, 2027 (estimated)
Completion
Apr 4, 2032 (estimated)
Last update
Mar 17, 2026

Study contacts

Chloé BOST, MD, PhD
Contact
bost.c@chu-toulouse.fr
5 61 77 61 44 ext. 0033
Chloé BOST, MD, PhD
principal investigator · University Hospital, Toulouse

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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