An observational study in Sjogren's Syndrome and Tomography Optical Coherence, sponsored by Centre Hospitalier de Mâcon. Recruiting at 1 site in France. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-06-12.
Sponsored by Centre Hospitalier de Mâcon · Observational
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.
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.
371 studies on the registry are indexed under Sjogren's Syndrome; 104 are open to participants now.
This study's planned enrollment of 30 is below the median of 114 across 113 observational studies indexed under Sjogren's Syndrome.
Browse Sjogren's Syndrome studies →Centre Hospitalier de Mâcon is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
TOCOSS cohort : Patient > 18 years old with suspected Sjogren Syndrome received minor gland salivary biopsy
Exclusion Criteria:
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
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
Plan to share: No
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Centre Hospitalier de Mâcon