NCT01807689

Salivary Biomarkers for Sjögren's Syndrome Detection

Salivary Biomarkers for Sjögren's Syndrome Detection - A Multi-Center Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 420 (actual)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center clinical study to compare the performance of a collective panel of salivary biomarkers to discriminate SS from non-SS in sicca cohorts recruited from three clinical sites with the diagnostic outcomes based on the new classification criteria for Sjögren's syndrome by the American College of Rheumatology (ACR) developed in 2012. This is not a treatment study, but a pilot study to confirm diagnostic ability of a panel of salivary biomarkers. All enrolled subjects must be classified as having both oral and ocular sicca symptoms without another autoimmune/connective tissue disease (Appendix 2). At the University of California in Los Angeles, using molecular techniques, we will quantify discriminatory biomarkers in saliva collected from enrolled subjects, who are also being evaluated as part of their clinical care using the standard diagnostic tests of the 2002 AECG criteria. We also will test the performance of these biomarkers to predict the diagnosis of pSS according to the AECG criteria, as these are the most widely used tests to diagnose pSS and assess disease activity worldwide.

Detailed description

Aim 1: Test the association using Odds Ratios between seven individual biomarkers (cathepsin D, α-enolase and β-2-microglobulin \[B2M\], anti-SSA, anti-SSB, anti-histone, anti-transglutaminase) with pSS and build an initial panel and evaluate its sensitivity and specificity for diagnosis of SS at the time of interim analysis using the first 210 recruited subjects. Hypothesis 1: Individual biomarkers are significantly associated with SS. Hypothesis 2: The panel has sufficient sensitivity and specificity for diagnosis of SS. Aim 2: Test the panel on the second 210 recruited subjects, refine and evaluate the panel sensitivity and specificity on entire 420 subjects. Hypothesis 1: The panel built from Aim 1 has sufficient sensitivity and specificity for diagnosis of SS. Hypothesis 2: The refined panel has sufficient sensitivity and specificity for diagnosis of SS.

Conditions

• Sjögren's Syndrome

Timeline

• Start date: 2013-04-01
• Primary completion: 2018-08-01
• Completion: 2018-09-01
• First posted: 2013-03-08
• Last updated: 2019-04-19

Locations

1 site across 1 country: United States