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Completed

NCT Number: NCT05528809

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sampling

Other

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

Primary outcomes

  1. Circulating epithelial cell detection rate

    Time frame: day 0

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

Secondary outcomes

  1. Number of circulating epithelial cells

    Time frame: day 0

  2. Number of circulating epithelial cells expressing human epidermal growth factor receptor 2 (HER2)

    Time frame: day 0

  3. Number of circulating epithelial and endothelial cells

    Time frame: day 0

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Acronym: CIRCEE

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Sep 6, 2022
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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