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

Sjogren's Syndrome Clinical Trial

— TOCOSS  

Official title:

Histopathological Analysis of Minor Salivary Gland Biopsy Following Dynamic Full-field Optical Coherence Tomography, a Comparison to Conventional Histopathological Findings in Patients Suspect Sjogren Syndrome.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06454370
• Other study ID #: TOCOSS
• Status: Recruiting
• Start date: June 7, 2024
• Est. completion date: December 7, 2024

Study information

• Verified date: June 2024
• Source: Centre Hospitalier de Mâcon
• Contact: Thibault MAILLET
• Phone: +33 3 85 27 73 43
• Email: thmaillet[@]ch-macon.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 7, 2024
• Est. primary completion date: October 7, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Sjogren's Syndrome
• Syndrome

Locations

Country	Name	City	State
France	Centre Hospitalier de Mâcon	Mâcon	Sâone-et-Loire

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier de Mâcon	Centre Hospitalier Universitaire Dijon, Centre Hospitalier William Morey - Chalon sur Saône

Country where clinical trial is conducted

France, 

References & Publications (3)

Maldiney T, Greigert H, Martin L, Benoit E, Creuzot-Garcher C, Gabrielle PH, Chassot JM, Boccara C, Balvay D, Tavitian B, Clement O, Audia S, Bonnotte B, Samson M. Full-field optical coherence tomography for the diagnosis of giant cell arteritis. PLoS One — View Citation

Manuel RC, Pilar BZ, Raphaele S, Hendrika B, Simon J B, Thomas D, Jacques-Eric G, Xavier M, Elke T, Stefano B, Salvatore V, Thomas M, Wan-Fai N, Aike K, Athanasios T, Claudio V; EULAR Sjogren Syndrome Task Force. Characterization of systemic disease in pr — View Citation

Shiboski CH, Shiboski SC, Seror R, Criswell LA, Labetoulle M, Lietman TM, Rasmussen A, Scofield H, Vitali C, Bowman SJ, Mariette X; International Sjogren's Syndrome Criteria Working Group. 2016 American College of Rheumatology/European League Against Rheu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Histopathological analysis of healthy minor salivary gland biopsy with dynamic full-field optical coherence tomography	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)	Outcome measure is assessed 15 days following minor salivary gland biopsy
Secondary	Histopathological analysis of Sjogren's syndrom minor salivary gland biopsy with dynamic full-field optical coherence tomography	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	Outcome measure is assessed 15 days following minor salivary gland biopsy