RecruitingNCT06454370

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

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.


Sponsor

Centre Hospitalier de Mâcon

Enrollment

30 participants

Start Date

Jun 7, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study compares traditional biopsy analysis (looking at tissue under a microscope) with a newer imaging technology called Full-field Optical Coherence Tomography (FFLOCT) — which creates high-resolution 3D images of tissue — for diagnosing Sjogren's syndrome, a condition where the immune system attacks moisture-producing glands causing dry eyes and dry mouth. **You may be eligible if...** - You are over 18 years old with suspected Sjogren's syndrome - You are already having a minor salivary gland biopsy (a small sample from the inner lip) as part of your diagnostic workup **You may NOT be eligible if...** - You are unable to undergo the FFLOCT imaging observation at the time of the biopsy procedure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Centre Hospitalier de Mâcon

Mâcon, Sâone-et-Loire, France

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NCT06454370


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