Lupus ErythematosusESSAiNCT05251415
Clinico-biological Collection to Investigate the Physiopathology of Systemic Autoimmune Diseases
An observational study of Lupus Erythematosus and Scleroderma, run by University Hospital, Toulouse at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 99 years
- Conditions the study is for
- Lupus Erythematosus, Scleroderma, Myositis
- What is being tested?
- Blood sampling
- How many people
- 3,000 participants
- Where
- 1 siteFrance
- Study dates
- 4 Apr 2022to 4 Apr 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with autoimmune diseases
Who may be able to join
- 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.).
Who cannot join
- Known anemia and hemoglobin <10 g / dl
- Patients under protective supervision (guardianship, curators)
- Pregnant or breastfeeding woman
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Purpan University Hospital
Toulouse, 31059
Chloé Bost, PharmD, PhD, 5 61 77 61 44 ext. 0033, bost.c@chu-toulouse.fr
About this study
Official title: Constitution of a Collection of Biological Samples With the Aim of Carrying Out Clinico-biological and Pathophysiological Investigations 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
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.
- Being tested
- Blood sampling
- Keywords
- systemic autoimmune diseases, scleroderma, lupus, myositis, vasculitis, Inflammatory Bowel Diseases, new therapies
- Medical subject headings
- Scleroderma, Diffuse, Myositis, Vasculitis, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingBiological
Blood will be taken in larger quantity.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
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)
Measured: through study completion, an average of 1 year
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)
Measured: 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
Use of immune cells and / or biological samples for transcriptomic and / or proteomic studies, or in order to be used in experimental animal models
Measured: through study completion, an average of 1 year
Identification of the determinants of immune reconstitution after cell therapy
Exploring blood cell populations before and after cell therapy with flow cytometry
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start4 Apr 2022
- Primary completion4 Apr 2027 (estimated)
- Study completion4 Apr 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chloé BOST, MD, PhD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05251415
- Sponsor's protocol ID
- RC31/21/0505
- Acronym
- ESSAi
- Status last verified
- Mar 2026
- First submitted
- 24 Jan 2022
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- ESSAi / RC31/21/0505
- Keywords
- systemic autoimmune diseases, scleroderma, lupus, myositis, vasculitis, Inflammatory Bowel Diseases, new therapies
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 4 Apr 2027 (estimated)
- Study completion
- 4 Apr 2032 (estimated)
- First posted
- 22 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients suffering from autoimmune disease | – | Biological: Blood samplingBiological samples will be collected in the normal diagnosis and follow-up process. Only blood will be taken in larger quantity. |
Who may qualify
- Ages
- 6 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with autoimmune diseases
Key inclusion criteria (3 listed)
- 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.).
Key exclusion criteria (3 listed)
- Known anemia and hemoglobin <10 g / dl
- Patients under protective supervision (guardianship, curators)
- Pregnant or breastfeeding woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingBlood will be taken in larger quantity. | Biological | patients suffering from autoimmune disease |
Primary outcome
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
4 secondary outcomes
Identification and / or validation of new biomarkers for diagnostic and / or prognostic purposes
Time frame: through study completion, an average of 1 year
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
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
Identification of the determinants of immune reconstitution after cell therapy
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chloé BOST, MD, PhD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lupus Erythematosus and Scleroderma, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chloé BOST, MD, PhD (5 61 77 61 44 ext. 0033, bost.c@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.