Clinico-biological Collection to Investigate the Physiopathology of Systemic Autoimmune Diseases
Observational · No treatment assigned · 1 site · University Hospital, Toulouse
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Lupus Erythematosus, Scleroderma and Myositis. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 6 to 99
- Any sex
Some of the main requirements, copied from the record:
- 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.).
There are also 3 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 3000 participants are expected to take part.
- Start date: 2022-04-04.
- Main results expected around 2027-04-04 (estimate from the record).
- 1 study site listed (1 marked recruiting) in France.
Main thing being measured
- Constitution of a collection of biological samples and clinical-biological data from patients with autoimmune diseases (through study completion, an average of 1 year)
In the researchers’ words
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
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Lupus Erythematosus; Scleroderma; Myositis; Vasculitis; Inflammatory Bowel Diseases |
| Lead sponsor | University Hospital, Toulouse |
| Enrollment | 3000 (estimated) |
| Start date | 2022-04-04 |
| Primary completion (est.) | 2027-04-04 |
| First posted | 2022-02-22 |
| Last updated | 2026-03-17 |
| Official title | Constitution of a Collection of Biological Samples With the Aim of Carrying Out Clinico-biological and Pathophysiological Investigations of Systemic Autoimmune Diseases |
| ClinicalTrials.gov ID | NCT05251415 |
Interventions
- Blood sampling (Biological)
Blood will be taken in larger quantity.
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Purpan University Hospital | Toulouse | France | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.