Comparing two methods for diagnosing Sjogren's Syndrome using salivary gland biopsies
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.
This study is testing whether a new imaging method can diagnose Sjögren's Syndrome faster and more accurately than the traditional biopsy analysis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Centre Hospitalier de Mâcon Academic / other |
| Locations | 1 site (Mâcon, Sâone-et-Loire) |
| Trial ID | NCT06454370 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare the effectiveness of histopathological analysis and full-field optical coherence tomography (FF-OCT) in diagnosing primary Sjögren syndrome (pSS) through minor salivary gland biopsies. It utilizes data from biopsies performed as part of standard care, allowing for a direct comparison of the two diagnostic methods without requiring additional procedures. The study focuses on evaluating the sensitivity and speed of diagnosis provided by FF-OCT compared to traditional histopathological examination.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who have suspected Sjogren Syndrome and are undergoing a minor salivary gland biopsy.
Not a fit: Patients who are unable to undergo dynamic full-field optical coherence tomography observation at the time of biopsy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to faster and more accurate diagnoses of Sjogren's Syndrome, improving patient management.
How similar studies have performed: While the use of FF-OCT has shown promise in other contexts, this specific comparison in diagnosing Sjogren's Syndrome is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Mâcon, Sâone-et-Loire
- Centre Hospitalier de Mâcon — Mâcon, Sâone-et-Loire, France (Recruiting)
Study contacts
- Principal investigator: Thibault MAILLET — Internal Medicine - Centre Hospitalier de Mâcon
- Study coordinator: Thibault MAILLET
- Email: thmaillet@ch-macon.fr
- Phone: +33 3 85 27 73 43
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.