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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorCentre Hospitalier de Mâcon

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

TOCOSS cohort : Patient \> 18 years old with suspected Sjogren Syndrome received minor gland salivary biopsy

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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)

Time frame
Outcome measure is assessed 15 days following minor salivary gland biopsy

Secondary outcomes

1

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

Time frame
Outcome measure is assessed 15 days following minor salivary gland biopsy

Other outcomes

Sponsors and contacts

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Centre Hospitalier de Mâcon

Lead sponsor

Centre Hospitalier William Morey - Chalon sur Saône

Collaborator

Centre Hospitalier Universitaire Dijon

Collaborator