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

NCT06454370 | Recruiting

• 1 other identifier: TOCOSS
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Sjogren's Syndrome; Tomography Optical Coherence

Keywords

Minor Salivary gland biopsy; Tomography, Optical Coherence

Outcome Measures

Primary Outcomes (1)

• 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)

  Outcome measure is assessed 15 days following minor salivary gland biopsy

Secondary Outcomes (1)

• Histopathological analysis of Sjogren's syndrom minor salivary gland biopsy with dynamic full-field optical coherence tomography

  Outcome measure is assessed 15 days following minor salivary gland biopsy

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

TOCOSS cohort : Patient \> 18 years old with suspected Sjogren Syndrome received minor gland salivary biopsy

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier de Mâcon: lead
• Centre Hospitalier William Morey - Chalon sur Saône: collaborator
• Centre Hospitalier Universitaire Dijon: collaborator

Study Sites (1)

Centre Hospitalier de Mâcon

Mâcon, Sâone-et-Loire, 71000, France

RECRUITING

Related Publications (3)

• 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.

  PMID: 28379527 RESULT

• 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.

  PMID: 27785888 RESULT

• 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.

  PMID: 32866179 RESULT

MeSH Terms

Conditions

Sjogren's Syndrome

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Thibault MAILLET

  Internal Medicine - Centre Hospitalier de Mâcon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thibault MAILLET

CONTACT

+33 3 85 27 73 43; thmaillet@ch-macon.fr

Thomas MALDINEY

CONTACT

+33 3 85 91 01 11; thomas.maldiney@ch-chalon71.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 12, 2024
• Study Start: June 7, 2024
• Primary Completion: October 7, 2024
• Study Completion: December 7, 2024
• Last Updated: June 12, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)