跳至主要内容
临床试验/NCT06454370
NCT06454370招募中不适用

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.

Centre Hospitalier de Mâcon1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年6月7日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
Histopathological analysis of healthy minor salivary gland biopsy with dynamic full-field optical coherence tomography

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Histopathological analysis of healthy minor salivary gland biopsy with dynamic full-field optical coherence tomography

时间窗: Outcome measure is assessed 15 days following minor salivary gland biopsy

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)

次要结局

  • 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)

研究者

发起方
Centre Hospitalier de Mâcon
申办方类型
Other
责任方
Sponsor

研究点 (1)

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