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

NCT05251415 | Recruiting

• 1 other identifier: RC31/21/0505
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

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

Outcome Measures

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

  through study completion, an average of 1 year

Secondary Outcomes (4)

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

  through study completion, an average of 1 year

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

  through study completion, an average of 1 year

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

  through study completion, an average of 1 year

• Identification of the determinants of immune reconstitution after cell therapy

  through study completion, an average of 1 year

Study Arms (1)

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

Blood sampling BIOLOGICAL

Blood will be taken in larger quantity.

patients suffering from autoimmune disease

Eligibility Criteria

• Age: 6 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with autoimmune diseases

You may qualify if:

• 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.).

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Purpan University Hospital

Toulouse, 31059, France

RECRUITING

MeSH Terms

Conditions

Scleroderma, Diffuse; Myositis; Vasculitis; Inflammatory Bowel Diseases

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Scleroderma, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Chloé BOST, MD, PhD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chloé BOST, MD, PhD

CONTACT

5 61 77 61 44; bost.c@chu-toulouse.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: February 22, 2022
• Study Start: April 4, 2022
• Primary Completion (Estimated): April 4, 2027
• Study Completion (Estimated): April 4, 2032
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)