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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.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06454370
Acronym
TOCOSS
Enrollment
30
Registered
2024-06-12
Start date
2024-06-07
Completion date
2024-12-07
Last updated
2024-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sjogren's Syndrome, Tomography Optical Coherence

Keywords

Minor Salivary gland biopsy, Tomography, Optical Coherence

Brief 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.

Detailed description

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.

Interventions

None listed

Sponsors

Centre Hospitalier William Morey - Chalon sur Saône
CollaboratorOTHER
Centre Hospitalier Universitaire Dijon
CollaboratorOTHER
Centre Hospitalier de Mâcon
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Histopathological analysis of healthy minor salivary gland biopsy with dynamic full-field optical coherence tomographyOutcome measure is assessed 15 days following minor salivary gland biopsyProvide 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

MeasureTime frameDescription
Histopathological analysis of Sjogren's syndrom minor salivary gland biopsy with dynamic full-field optical coherence tomographyOutcome measure is assessed 15 days following minor salivary gland biopsyProvide 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

Countries

France

Contacts

Primary ContactThibault MAILLET
thmaillet@ch-macon.fr+33 3 85 27 73 43
Backup ContactThomas MALDINEY
thomas.maldiney@ch-chalon71.fr+33 3 85 91 01 11

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026