Primary Gougerot-Sjögren SyndromeCIRCEENCT05528809
Quantification and Characterization of Circulating Epithelial and Endothelial Cells in Gougerot-Sjögren Syndrome, Compared to Systemic Sclerosis
A study testing Blood sampling in people with Primary Gougerot-Sjögren Syndrome and Systemic Sclerosis, Diffuse, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Primary Gougerot-Sjögren's syndrome is a systemic autoimmune disease belonging to the group of connectivities, whose physiopathology remains largely unknown. Quantification and characterization of epithelial and endothelial circulants in Gougerot-Sjögren's syndrome could reflect the intensity of the epithelial… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Primary Gougerot-Sjögren Syndrome, Systemic Sclerosis, Diffuse
- What is being tested?
- Blood sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 27 Sep 2022to 25 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients over the age of 18
- Written and signed consent by the participant and the investigator
- Affiliated person or beneficiary of the social security system
- Test group: patients with Gougerot-Sjögren's syndrome connectivitis meeting the ACR/EULAR classification criteria
- Positive control group: patients with diffuse systemic scleroderma connectivitis meeting ACR/EULAR classification criteria
Who cannot join
- Association of the two diseases in the same patient
- Progressive cancer
- Subject protected by law, under guardianship or curatorship
- Inability to give free and informed consent to participate in the study
- Withdrawal of consent
Trial locations and contacts
1 site in 1 country.
About this study
Primary Gougerot-Sjögren's syndrome is a systemic autoimmune disease belonging to the group of connectivities, whose physiopathology remains largely unknown. Quantification and characterization of epithelial and endothelial circulants in Gougerot-Sjögren's syndrome could reflect the intensity of the epithelial aggression, and thus possibly constitute a biomarker.
Read the detailed description
Primary Gougerot-Sjögren's syndrome is a systemic autoimmune disease belonging to the group of connectivities.
The criteria for classification of the disease include dry syndrome, positive salivary gland biopsy and detection of anti-Sjögren's-syndrome-related antigen A (anti-SSA) and anti-Sjögren's-syndrome-related antigen B (anti-SSB) antibodies. The presence of antibodies is thus important for the diagnosis but not essential, because in some patients the salivary gland biopsy is positive and the antibodies are absent. Therefore, the identification of new biomarkers could be very useful to confirm the diagnosis of primary Gougerot-Sjögren's syndrome and to identify subgroups of patients.
The pathophysiology of the disease remains largely unknown. Currently, primary Gougerot-Sjögren's syndrome is thought to originate from inflammation of the epithelial tissue of the salivary glands. However, it is currently unknown whether this autoimmune epithelitis is accompanied by a contingent of circulating epithelial cells, the characterization of which might be accessible by liquid biopsy.
So far, the circulating epithelial cells that have been identified have been identified in the context of cancer: in this case they are called circulating tumor cells. Their detection during primary Gougerot-Sjögren's syndrome could reflect the intensity of epithelial aggression, and thus possibly constitute a biomarker.
In other connectivities, data on circulating cells have already been published. In systemic scleroderma, another connectivitis affecting mainly middle-aged women, circulating progenitor cells have already been detected and are thought to have the capacity to differentiate into endothelial cells, thus playing a potentially important role in the pathophysiology of the disease.
- Being tested
- Blood sampling
- Keywords
- Sjögren's syndrome, systemic sclerosis, progenitor cells, circulating endothelial cells, circulating epithelial cells, endothelium, epithelium, autoimmune diseases, connective tissue disorders
- Medical subject headings
- Scleroderma, Diffuse, Sjogren's Syndrome, Scleroderma, Systemic, Autoimmune Diseases, Connective Tissue Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingOther
A blood sampling will be performed during the inclusion visit (day 0).
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Patients with Gougerot-Sjögren's syndrome meeting American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) disease definitions Receives: Other: Blood sampling |
| Positive control group | Active comparator | Patients with diffuse systemic scleroderma meeting American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) disease definitions Receives: Other: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circulating epithelial cell detection rate
Rate of patients with at least 1 circulating epithelial cell in the peripheral blood
Measured: day 0
Secondary outcomes (3)
Number of circulating epithelial cells
Measured: day 0
Number of circulating epithelial cells expressing human epidermal growth factor receptor 2 (HER2)
Measured: day 0
Number of circulating epithelial and endothelial cells
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 posted6 Sep 2022
- Study start27 Sep 2022
- Primary completion12 Oct 2022
- Study completion25 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Gougerot-Sjögren SyndromeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This a single-center prospective comparative non-randomized cohort pilot study, with 2 parallel groups (experimental group : patients with Gougerot-Sjögren's syndrome and positive control group : patients with diffuse systemic scleroderma).
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe GUILPAIN, MD, PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05528809
- Sponsor's protocol ID
- RECHMPL22_0043
- Acronym
- CIRCEE
- Status last verified
- Sep 2025
- First submitted
- 1 Sep 2022
- Last updated
- 30 Sep 2025
- 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 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification and Characterization of Circulating Epithelial and Endothelial Cells in Gougerot-Sjögren Syndrome, Compared to Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT05528809
- Acronym / sponsor ID
- CIRCEE / RECHMPL22_0043
- Keywords
- Sjögren's syndrome, systemic sclerosis, progenitor cells, circulating endothelial cells, circulating epithelial cells, endothelium, epithelium, autoimmune diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 27 Sep 2022 (actual)
- Primary completion
- 12 Oct 2022 (actual)
- Study completion
- 25 Jan 2023 (actual)
- First posted
- 6 Sep 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.
Primary Gougerot-Sjögren's syndrome is a systemic autoimmune disease belonging to the group of connectivities, whose physiopathology remains largely unknown. Quantification and characterization of epithelial and endothelial circulants in Gougerot-Sjögren's syndrome could reflect the intensity of the epithelial aggression, and thus possibly constitute a biomarker.
Detailed description
Primary Gougerot-Sjögren's syndrome is a systemic autoimmune disease belonging to the group of connectivities.
The criteria for classification of the disease include dry syndrome, positive salivary gland biopsy and detection of anti-Sjögren's-syndrome-related antigen A (anti-SSA) and anti-Sjögren's-syndrome-related antigen B (anti-SSB) antibodies. The presence of antibodies is thus important for the diagnosis but not essential, because in some patients the salivary gland biopsy is positive and the antibodies are absent. Therefore, the identification of new biomarkers could be very useful to confirm the diagnosis of primary Gougerot-Sjögren's syndrome and to identify subgroups of patients.
The pathophysiology of the disease remains largely unknown. Currently, primary Gougerot-Sjögren's syndrome is thought to originate from inflammation of the epithelial tissue of the salivary glands. However, it is currently unknown whether this autoimmune epithelitis is accompanied by a contingent of circulating epithelial cells, the characterization of which might be accessible by liquid biopsy.
So far, the circulating epithelial cells that have been identified have been identified in the context of cancer: in this case they are called circulating tumor cells. Their detection during primary Gougerot-Sjögren's syndrome could reflect the intensity of epithelial aggression, and thus possibly constitute a biomarker.
In other connectivities, data on circulating cells have already been published. In systemic scleroderma, another connectivitis affecting mainly middle-aged women, circulating progenitor cells have already been detected and are thought to have the capacity to differentiate into endothelial cells, thus playing a potentially important role in the pathophysiology of the disease.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This a single-center prospective comparative non-randomized cohort pilot study, with 2 parallel groups (experimental group : patients with Gougerot-Sjögren's syndrome and positive control group : patients with diffuse systemic scleroderma).
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Blood samplingPatients with Gougerot-Sjögren's syndrome meeting American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) disease definitions |
| Positive control group | Active comparator | Other: Blood samplingPatients with diffuse systemic scleroderma meeting American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) disease definitions |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female patients over the age of 18
- Written and signed consent by the participant and the investigator
- Affiliated person or beneficiary of the social security system
- Test group: patients with Gougerot-Sjögren's syndrome connectivitis meeting the ACR/EULAR classification criteria
- Positive control group: patients with diffuse systemic scleroderma connectivitis meeting ACR/EULAR classification criteria
Key exclusion criteria (5 listed)
- Association of the two diseases in the same patient
- Progressive cancer
- Subject protected by law, under guardianship or curatorship
- Inability to give free and informed consent to participate in the study
- Withdrawal of consent
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 samplingA blood sampling will be performed during the inclusion visit (day 0). | Other | Experimental group, Positive control group |
Primary outcome
Circulating epithelial cell detection rate
Time frame: day 0
Rate of patients with at least 1 circulating epithelial cell in the peripheral blood
3 secondary outcomes
Number of circulating epithelial cells
Time frame: day 0
Number of circulating epithelial cells expressing human epidermal growth factor receptor 2 (HER2)
Time frame: day 0
Number of circulating epithelial and endothelial cells
Time frame: day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
Philippe GUILPAIN, MD, PhD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling in people with Primary Gougerot-Sjögren Syndrome and Systemic Sclerosis, Diffuse, run by University Hospital, Montpellier 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 30 Sep 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circulating epithelial cell detection rate (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 30 Sep 2025.