Histopathological Analysis Versus Full-field Optical Coherence Tomography of Minor Salivary Gland Biopsy in Suspect Sjogren Syndrome

Recruiting

• Conditions: Sjogren's Syndrome; Tomography Optical Coherence

• Registration Number: NCT06454370
• Lead Sponsor: Centre Hospitalier de Mâcon

Brief Summary

Primary Sjögren syndrome (pSS) is a systemic autoimmune disease that mainly affects the exocrine glands leading to severe dryness of mucosal surfaces, principally in the mouth and eyes. The other clinical manifestations are fatigue and musculoskeletal pain. Diagnosis of pSS associates clinical abnormalities with specific antibodies (Ro/SSA and La/SSB antibodies) or histopathological criteria of a minor salivary gland biopsy (the presence and number of lymphocytic focus, as well as chronicity findings like acinar atrophy, ductal dilatation or fibrosis). Apart from its variable sensitivity, one of the weaknesses of minor salivary gland biopsy is the delay in obtaining the result due to the time required to prepare the sample for histological analysis.

Our group recently demonstrated the use of full-field optical coherence tomography (FF-OCT) to visualize structural changes associated with the inflammatory processes in Giant Cell Arteritis (temporal artery biopsy examination). It may suggests a further use of dynamic FF-OCT of minor salivary gland biopsy to visualize structural changes associated with the lymhocytic focus to ensure rapid on-site diagnosis of pSS.

Detailed Description

This study does not require additional examination, and will use the data performed from the minor salivary gland biopsy carried out as part of usual care, in comparison with the results of the conventional histopathological examination.

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-06
• Study Start: 2024-06-07
• Study First Submitted QC: 2024-06-11
• Last Update Submitted: 2024-06-11
• Study First Posted: 2024-06-12
• Last Update Posted: 2024-06-12
• Primary Completion: 2024-10-07
• Study Completion: 2024-12-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patient > 18 years of age with suspected Sjogren Syndrome received minor gland salivary biopsy

Exclusion Criteria

• Inability to perform dynamic full-field optical coherence tomography observation at the moment of temporal artery biopsy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Histopathological analysis of healthy minor salivary gland biopsy with dynamic full-field optical coherence tomography	Outcome measure is assessed 15 days following minor salivary gland biopsy	Provide a better understanding of the ability of dynamic full-field optical coherence tomography to identify the normal structures of a minor salivary gland biopsy, i.e . salivary parenchyma with secretory units arranged into acini (group of acinar cells organized around a narrow lumen)

Secondary Outcome Measures

Name	Time	Method
Histopathological analysis of Sjogren's syndrom minor salivary gland biopsy with dynamic full-field optical coherence tomography	Outcome measure is assessed 15 days following minor salivary gland biopsy	Provide a better understanding of the ability of dynamic full-field optical coherence tomography to identify histopathological features of Sjogren syndrom, i.e. lymphocytic foci, particularly located in the periductal area (according to the classification defined by Chisholm and Mason), acinar atrophy, ductal dilatation, and fibrosis

Trial Locations

Locations (1)

Centre Hospitalier de Mâcon; 🇫🇷 Mâcon, Sâone-et-Loire, France