ClinicalTrials.gov record NCT06387654
Clinico-biological Collection of Autoimmune, Dysimmune or Auto-inflammatory Dermatological Diseases
Constitution of a Collection of Biological Samples With the Aim of Carrying Out Clinico-biological and Physiopathological Investigations of Autoimmune, Dysimmune or Auto-inflammatory Dermatological Diseases
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This is a prospective observational study that builds a clinical and biological sample collection from people with autoimmune, dysimmune, or auto-inflammatory skin diseases. Researchers will store blood and leftover samples taken during routine care to support lab studies. The collection is intended to help identify biomarkers, autoantibodies, and to explore disease mechanisms.
What it is studying. The study aims to identify new biomarkers and autoantibodies and to investigate the biological mechanisms behind autoimmune, dysimmune, and auto-inflammatory skin diseases by analyzing collected samples and clinical data.
What the researchers hope to learn. Build a repository of clinical data and biological samples from patients with autoimmune, dysimmune, or auto-inflammatory skin diseases; identify new autoantibodies; find biomarkers related to disease severity; explore pathophysiological mechanisms (including cell profiling and transcriptomics) and compare immune cell populations before and after cell therapies.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
The aim of this project is to start a biological and clinical collection of patients presenting autoimmune, dysimmune or auto-inflammatory dermatological diseases. 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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Biological
- Blood sampling
- Remainders of samples taken as part of the treatment
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Skin damage of documented or probable autoimmune, dysimmune or autoinflammatory origin.
- The patients included may be adults or children, and will be:
- Patients with autoimmune bullous dermatoses (pemphigus, pemphigoid and others),
- Patients with systemic autoimmune diseases associated with skin damage (lupus, scleroderma, dermatomyositis for example),
- Patients with cutaneous lupus
- Patients with dysimmune skin diseases (psoriasis, eczema)
- Patients with immuno-induced dermatological disorders or drug dermatitis
- Patients receiving, or likely to receive, new, innovative therapies (new molecule on the market, checkpoint inhibitors, gene therapy, cell therapy, etc.).
- Patients with dermatological damage whose autoimmune, dysimmune or auto-inflammatory origin is suspected
Exclusion criteria
- Patients under protective supervision (guardianship, curators)
- Patients under 6 years old
- Pregnant or breastfeeding woman
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Detailed description from the registry
Autoimmune diseases include around 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.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants give blood samples (the record notes blood may be taken in larger quantity) and allow leftover clinical samples to be stored. Leftover samples may include blood, cerebrospinal fluid (CSF, i.e. spinal tap) when collected as part of care, saliva, stool, urine, other biological fluids, tissue biopsies and hair follicles. Samples and clinical data are collected at enrollment (Day 0) and during routine diagnosis and follow‑up; the record indicates follow‑up through study completion with an average of about 1 year. Samples and data are used for laboratory and biological analyses; no investigational treatment is assigned by this study per the registry.
How the study is structured. This is a prospective observational cohort study. Participants provide blood and leftover biological samples taken during their normal diagnosis or follow-up; their clinical data are stored and studied. No experimental treatments are assigned by the study. Follow-up and sample collection continue through study completion (about one year on average).
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The listed sites are in France. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on dermatomyositis
This trial is also listed on this site under polymyositis.
Important dates
- Study start
- May 6, 2024
- Primary completion
- April 2029 (estimated)
- Study completion
- April 2034 (estimated)
- Target enrollment
- 800 participants (estimated)
- Last updated on registry
- Mar 17, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- University Hospital, Toulouse
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Chloé BOST, MD, PhD 📞 5 61 77 61 44 ext. 0033 ✉ bost.c@chu-toulouse.fr
Participating sites (1)
- University HospitalRecruiting
Toulouse, 31059 · France
- Chloé BOST, MD, PhD · 5 61 77 61 44 ext. 0033 · bost.c@chu-toulouse.fr
Terms used on this page · explanations by MedicalUpdates.ai
- biomarkers
- Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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