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 volunteersQualifiers
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
Other
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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)
Secondary outcomes
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
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Centre Hospitalier de Mâcon
Lead sponsor
Centre Hospitalier William Morey - Chalon sur Saône
Collaborator
Centre Hospitalier Universitaire Dijon
Collaborator