Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06454370
Status:
RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-06-06
Brief Title:
Histopathological Analysis Versus Full-field Optical Coherence Tomography of Minor Salivary Gland Biopsy in Suspect Sjogren Syndrome
Sponsor:
Centre Hospitalier de Mâcon
Organization:
Centre Hospitalier de Mâcon
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TOCOSS
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 RoSSA and LaSSB 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None