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Quantification and Characterization of Circulating Epithelial and Endothelial Cells in Gougerot-Sjögren Syndrome, Compared to Systemic Sclerosis

Quantification and Characterization of Circulating Epithelial and Endothelial Cells in Gougerot-Sjögren Syndrome, Compared to Systemic Sclerosis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05528809
Acronym
CIRCEE
Enrollment
40
Registered
2022-09-06
Start date
2022-09-27
Completion date
2023-01-25
Last updated
2025-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Gougerot-Sjögren Syndrome, Systemic Sclerosis, Diffuse

Keywords

Sjögren's syndrome, systemic sclerosis, progenitor cells, circulating endothelial cells, circulating epithelial cells, endothelium, epithelium, autoimmune diseases, connective tissue disorders

Brief 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 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.

Interventions

OTHERBlood sampling

A blood sampling will be performed during the inclusion visit (day 0).

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention 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).

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Circulating epithelial cell detection rateday 0Rate of patients with at least 1 circulating epithelial cell in the peripheral blood

Secondary

MeasureTime frame
Number of circulating epithelial cellsday 0
Number of circulating epithelial cells expressing human epidermal growth factor receptor 2 (HER2)day 0
Number of circulating epithelial and endothelial cellsday 0

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026