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

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.

Study Overview

• Status: Completed
• Conditions: Primary Gougerot-Sjögren Syndrome; Systemic Sclerosis, Diffuse
• Intervention / Treatment: Other: Blood sampling

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France
    • Montpellier University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Patients with Gougerot-Sjögren's syndrome meeting American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) disease definitions	Other: Blood sampling; A blood sampling will be performed during the inclusion visit (day 0).
Active Comparator: Positive control group; Patients with diffuse systemic scleroderma meeting American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) disease definitions	Other: Blood sampling; A blood sampling will be performed during the inclusion visit (day 0).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Circulating epithelial cell detection rate	Rate of patients with at least 1 circulating epithelial cell in the peripheral blood	day 0

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of circulating epithelial cells	day 0
Number of circulating epithelial cells expressing human epidermal growth factor receptor 2 (HER2)	day 0
Number of circulating epithelial and endothelial cells	day 0

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Philippe GUILPAIN, MD, PhD, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2022
• Primary Completion (Actual): October 12, 2022
• Study Completion (Actual): January 25, 2023

Study Registration Dates

• First Submitted: September 1, 2022
• First Submitted That Met QC Criteria: September 1, 2022
• First Posted (Actual): September 6, 2022

Study Record Updates

• Last Update Posted (Estimated): September 30, 2025
• Last Update Submitted That Met QC Criteria: September 26, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Sjögren's syndrome; systemic sclerosis; progenitor cells; circulating endothelial cells; circulating epithelial cells; endothelium; epithelium; autoimmune diseases; connective tissue disorders
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Mouth Diseases; Stomatognathic Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Immune System Diseases; Eye Diseases; Skin Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Skin and Connective Tissue Diseases; Sjogren's Syndrome; Autoimmune Diseases; Scleroderma, Systemic; Scleroderma, Diffuse; Connective Tissue Diseases; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Specimen Collection
• Other Study ID Numbers: RECHMPL22_0043

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No