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

NCT06454370 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2024-06-12

No results posted yet for this study

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.

Conditions

  • Sjogren's Syndrome
  • Tomography Optical Coherence

Sponsors & Collaborators

  • Centre Hospitalier William Morey - Chalon sur Saône

    collaborator OTHER
  • Centre Hospitalier Universitaire Dijon

    collaborator OTHER
  • Centre Hospitalier de Mâcon

    lead OTHER

Principal Investigators

  • Thibault MAILLET · Internal Medicine - Centre Hospitalier de Mâcon

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-07
Primary Completion
2024-10-07
Completion
2024-12-07

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06454370 on ClinicalTrials.gov