Autoimmune DiseasesSTIMEXNCT04978948
Study of STIM1 Membrane Expression
An observational study of Autoimmune Diseases, run by University Hospital, Brest at 4 sites in France.
Trial summary
The aim of this study is to determine the expression of STIM1 in the plasma membrane of lymphocytes from patients suffering from different autoimmune diseases in order to identify new pathologies of interest presenting an over-expression of STIM1PM. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Autoimmune Diseases
- How many people
- 670 participants
- Where
- 4 sitesFrance
- Study dates
- 11 May 2021to May 2027
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient over 18 years old. Diagnosis of one of the autoimmune diseases of interest according to the commonly accepted classification criteria for each disease, regardless of the level of disease activity.
Who may be able to join
- Diagnosis of one of the autoimmune diseases
Who cannot join
- Treatment with rituximab in the previous 12 months
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Recruiting
CHRU de Brest - Service de rhumatologie
Brest, Brest, 29200
Divi CORNEC, 02 98 34 72 64, divi.cornec@chu-brest.fr
- Recruiting
CHU de Martinique
Fort-de-France, Martinique, 97261
Benoit Suzon, benoit.suzon@chu-martinique.fr
- Recruiting
Centre Hospitalier des Pays de Morlaix
Morlaix, Brittany Region, 29672
Catherine Le Henaff
- Recruiting
Centre Hospitalier de Quimper
Quimper, Brittany Region, 29000
Jeremy Keraen
About this study
Official title: Study of STIM1 Membrane Expression During Autoimmune Diseases
The aim of this study is to determine the expression of STIM1 in the plasma membrane of lymphocytes from patients suffering from different autoimmune diseases in order to identify new pathologies of interest presenting an over-expression of STIM1PM.
This would allow to initiate, following this study, research and development programs on the use of anti-STIM1 antibodies in these identified autoimmune diseases of interest.
- Conditions
- Autoimmune Diseases
- Keywords
- autoimmune diseases
- Medical subject headings
- Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Myasthénie | Blood samples will be collected | |
| Myopathie inflammatoire (Myosite) | Blood samples will be collected | |
| Neuropathie autoimmune | Blood samples will be collected | |
| Néphropathies autoimmunes | Blood samples will be collected | |
| Hépatite auto-immune | Blood samples will be collected | |
| Pancréatite auto-immune | Blood samples will be collected | |
| Purpura Thrombopénique Immunologique | Blood samples will be collected | |
| Dermatose bulleuse | Blood samples will be collected | |
| Thyroïdite autoimmune | Blood samples will be collected | |
| Sclérose en plaque | Blood samples will be collected | |
| Sclérose latérale amyotrophique | Blood samples will be collected | |
| Polyarthrite Rhumatoïde | Blood samples will be collected | |
| Spondylarthrite axiale | Blood samples will be collected | |
| controls | Patients without autoimune desease* Blood samples will be collected | |
| Lichen plan buccal auto-immun (LPB) | Blood samples will be collected | |
| lichen plan buccal allo-immun liée à une GvHD (" Graft versus Host Disease ") | Blood samples will be collected | |
| Lupus érythémateux systémique | Blood samples will be collected | |
| Sclérodermie | Blood samples will be collected |
What is being measured
The primary outcome is the main question the study is designed to answer.
level of STIM1-PM
Membrane expression level of STIM1-PM on the surface of immune cells, measured by flow cytometry
Measured: Day 0
Secondary outcomes (1)
correlation between STIM1 expression and Clinical Score
Study of correlation between STIM1 expression on different cells and clinical scores of different autoimmune diseases or treatments received
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start11 May 2021
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune DiseasesStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 670 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04978948
- Sponsor's protocol ID
- STIMEX - 29BRC21.0025
- Acronym
- STIMEX
- Status last verified
- Jun 2026
- First submitted
- 4 May 2021
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of STIM1 Membrane Expression During Autoimmune Diseases
- ClinicalTrials.gov ID
- NCT04978948
- Acronym / sponsor ID
- STIMEX / STIMEX - 29BRC21.0025
- Conditions
- Autoimmune Diseases
- Keywords
- autoimmune diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 670 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 11 May 2021 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 27 Jul 2021 (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 study is to determine the expression of STIM1 in the plasma membrane of lymphocytes from patients suffering from different autoimmune diseases in order to identify new pathologies of interest presenting an over-expression of STIM1PM.
This would allow to initiate, following this study, research and development programs on the use of anti-STIM1 antibodies in these identified autoimmune diseases of interest.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 18
| Arm | Type | Receives |
|---|---|---|
| Myasthénie | – | –Blood samples will be collected |
| Myopathie inflammatoire (Myosite) | – | –Blood samples will be collected |
| Neuropathie autoimmune | – | –Blood samples will be collected |
| Néphropathies autoimmunes | – | –Blood samples will be collected |
| Hépatite auto-immune | – | –Blood samples will be collected |
| Pancréatite auto-immune | – | –Blood samples will be collected |
| Purpura Thrombopénique Immunologique | – | –Blood samples will be collected |
| Dermatose bulleuse | – | –Blood samples will be collected |
| Thyroïdite autoimmune | – | –Blood samples will be collected |
| Sclérose en plaque | – | –Blood samples will be collected |
| Sclérose latérale amyotrophique | – | –Blood samples will be collected |
| Polyarthrite Rhumatoïde | – | –Blood samples will be collected |
| Spondylarthrite axiale | – | –Blood samples will be collected |
| controls | – | –Patients without autoimune desease* Blood samples will be collected |
| Lichen plan buccal auto-immun (LPB) | – | –Blood samples will be collected |
| lichen plan buccal allo-immun liée à une GvHD (" Graft versus Host Disease ") | – | –Blood samples will be collected |
| Lupus érythémateux systémique | – | –Blood samples will be collected |
| Sclérodermie | – | –Blood samples will be collected |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient over 18 years old. Diagnosis of one of the autoimmune diseases of interest according to the commonly accepted classification criteria for each disease, regardless of the level of disease activity.
Key inclusion criteria (1 listed)
- Diagnosis of one of the autoimmune diseases
Key exclusion criteria (1 listed)
- Treatment with rituximab in the previous 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
level of STIM1-PM
Time frame: Day 0
Membrane expression level of STIM1-PM on the surface of immune cells, measured by flow cytometry
1 secondary outcome
correlation between STIM1 expression and Clinical Score
Time frame: Day 0
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 26 Jun 2026.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autoimmune Diseases, run by University Hospital, Brest at 4 sites 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 1 inclusion and 1 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 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 Divi Cornec (02 98 22 33 33, divi.cornec@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
level of STIM1-PM (time frame: Day 0). 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 26 Jun 2026.