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

NCT05528809 | Completed

• 1 other identifier: RECHMPL22_0043
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Circulating epithelial cell detection rate

  Rate of patients with at least 1 circulating epithelial cell in the peripheral blood

  day 0

Secondary Outcomes (3)

• 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

Study Arms (2)

Experimental group

EXPERIMENTAL

Patients with Gougerot-Sjögren's syndrome meeting American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) disease definitions

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

Other: Blood sampling

Interventions

Blood sampling OTHER

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

Experimental group; Positive control group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Montpellier University Hospital

Montpellier, France

Location

MeSH Terms

Conditions

Scleroderma, Diffuse; Sjogren's Syndrome; Scleroderma, Systemic; Autoimmune Diseases; Connective Tissue Diseases

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases; Skin Diseases; Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Philippe GUILPAIN, MD, PhD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: September 1, 2022
• First Posted: September 6, 2022
• Study Start: September 27, 2022
• Primary Completion: October 12, 2022
• Study Completion: January 25, 2023
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)