Clinical trial NCT06454370: Histopathological Analysis Versus Full-field Optical Coherence Tomography of Minor Salivary Gland Biopsy in Suspect Sjogren Syndrome
Official title: 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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sjogren's Syndrome
Tomography Optical Coherence
Keywords: Minor Salivary gland biopsy
Tomography, Optical Coherence
Lead sponsor: Centre Hospitalier de Mâcon
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier William Morey - Chalon sur Saône
name: Centre Hospitalier Universitaire Dijon
First posted: 2024-06-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: TOCOSS cohort : Patient \> 18 years old with suspected Sjogren Syndrome received minor gland salivary biopsy

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.

Eligibility criteria: 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

Primary outcomes:
measure: Histopathological analysis of healthy minor salivary gland biopsy with dynamic full-field optical coherence tomography
timeFrame: Outcome measure is assessed 15 days following minor salivary gland biopsy
Secondary outcomes:
measure: Histopathological analysis of Sjogren's syndrom minor salivary gland biopsy with dynamic full-field optical coherence tomography
timeFrame: Outcome measure is assessed 15 days following minor salivary gland biopsy
Other outcomes:
Locations:
city: Mâcon
country: France
facility: Centre Hospitalier de Mâcon
state: Sâone-et-Loire
Study officials:
affiliation: Internal Medicine - Centre Hospitalier de Mâcon
name: Thibault MAILLET
role: PRINCIPAL_INVESTIGATOR
References:
citation: Manuel RC, Pilar BZ, Raphaele S, Hendrika B, Simon J B, Thomas D, Jacques-Eric G, Xavier M, Elke T, Stefano B, Salvatore V, Thomas M, Wan-Fai N, Aike K, Athanasios T, Claudio V; EULAR Sjogren Syndrome Task Force. Characterization of systemic disease in primary Sjogren's syndrome: EULAR-SS Task Force recommendations for articular, cutaneous, pulmonary and renal involvements. Rheumatology (Oxford). 2017 Jul 1;56(7):1245. doi: 10.1093/rheumatology/kex157. No abstract available.
citation: Shiboski CH, Shiboski SC, Seror R, Criswell LA, Labetoulle M, Lietman TM, Rasmussen A, Scofield H, Vitali C, Bowman SJ, Mariette X; International Sjogren's Syndrome Criteria Working Group. 2016 American College of Rheumatology/European League Against Rheumatism Classification Criteria for Primary Sjogren's Syndrome: A Consensus and Data-Driven Methodology Involving Three International Patient Cohorts. Arthritis Rheumatol. 2017 Jan;69(1):35-45. doi: 10.1002/art.39859. Epub 2016 Oct 26.
citation: Maldiney T, Greigert H, Martin L, Benoit E, Creuzot-Garcher C, Gabrielle PH, Chassot JM, Boccara C, Balvay D, Tavitian B, Clement O, Audia S, Bonnotte B, Samson M. Full-field optical coherence tomography for the diagnosis of giant cell arteritis. PLoS One. 2020 Aug 31;15(8):e0234165. doi: 10.1371/journal.pone.0234165. eCollection 2020.