Salivary Biomarkers for Sjögren's Syndrome Detection
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Salivary Biomarkers for Sjögren's Syndrome Detection - A Multi-Center Study|
- With a PRoBE design, build an initial collective salivary biomarker panel to evaluate its ability to diagnose a Sjogrenn Syndrome (SS) patient. [ Time Frame: First 210 subjects up to 24 months. ] [ Designated as safety issue: No ]Test the association using Odds Ratios between seven individual salivary biomarkers (cathepsin D, α-enolase and β-2-microglobulin [B2M], anti-SSA, anti-SSB, anti-histone, anti-transglutaminase) in subjects suspect for SS and build an initial collective biomarker panel and evaluate its ability for accuracy in sensitivity and specificity in it's ability to make a diagnosis of SS using the first 210 recruited subjects. Each subject is a one time saliva collection for this study.
- Test the second 210 recruited subjects, refine and evaluate the collective saliva biomarker panel on entire 420 subjects. [ Time Frame: Full 420 subjects within 48 months ] [ Designated as safety issue: No ]Test the collective saliva biomarker panel on the second 210 recruited subjects, refine and evaluate the panel further for sensitivity and specificity (their ability to diagnose) on entire 420 SS study subjects. Enforcing the collective saliva biomarker panel diagnostic abilities.
Biospecimen Retention: Samples With DNA
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||April 2018|
|Estimated Primary Completion Date:||April 2018 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01807689
|Contact: David Wong, DMD, MDScemail@example.com|
|Contact: David Akinfirstname.lastname@example.org|
|United States, California|
|UCLA - School of Dentistry||Recruiting|
|Los Angeles, California, United States, 90095|
|Contact: David Wong, DMD, DMSc 310-206-3048 email@example.com|
|Contact: David Akin 310-825-9792 firstname.lastname@example.org|
|Sub-Investigator: Nelson Rhodus, DMD, MPH|
|Sub-Investigator: Arjan Vissink, DMD, MD, PhD|
|Sub-Investigator: Hal Scofield, MD|
|Principal Investigator:||David Wong, DMD, MDSc||University of California, Los Angeles|