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

Systemic Sclerosis, Diffuse Clinical Trial

— CIRCEE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05528809
• Other study ID #: 22_0043 _8173
• Status: Recruiting
• Phase: N/A
• Start date: October 12, 2022
• Est. completion date: October 1, 2024

Study information

• Verified date: October 2022
• Source: University Hospital, Montpellier
• Contact: Philippe GUILPAIN, MD, PhD
• Phone: +33 4 67 33 73 32
• Email: p-guilpain[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 aggression, and thus possibly constitute a biomarker.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Sjogren's Syndrome
• Syndrome
• Systemic Sclerosis, Diffuse

Intervention

Other:
• Blood sampling
A blood sampling will be performed during the inclusion visit (day 0).

Locations

Country	Name	City	State
France	Montpellier University Hospital	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Circulating epithelial cell detection rate	Rate of patients with at least 1 circulating epithelial cell in the peripheral blood	day 0
Secondary	Number of circulating epithelial cells		day 0
Secondary	Number of circulating epithelial cells expressing human epidermal growth factor receptor 2 (HER2)		day 0
Secondary	Number of circulating epithelial and endothelial cells		day 0