Salivary Biomarkers for Sjögren's Syndrome Detection

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01807689
Study type	Observational
Source	University of California, Los Angeles
Contact
Status	Completed
Phase
Start date	April 1, 2013
Completion date	September 1, 2018

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05946941` - A Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome	Phase 3
Completed	`NCT05633524` - HRR as a Novel Biomarker in Sjögren's Syndrome
Terminated	`NCT02843659` - Proof of Concept Study to Evaluate the Efficacy and Safety of BMS-931699 (Lulizumab) or BMS-986142 in Primary Sjögren's Syndrome	Phase 2
Completed	`NCT04129164` - A Study to Evaluate the Efficacy and Safety of VIB4920 in Participants With Sjögren's Syndrome	Phase 2
Completed	`NCT04798911` - SS-INQ Information Needs Questionnaire in Sjögren's Syndrome
Recruiting	`NCT05605665` - Low-dose Interleukin-2 and Rapamycin on sjögren's Syndrome	Phase 1/Phase 2
Completed	`NCT02833311` - e-Mobile Tablet for People With Chronic Conditions	N/A
Completed	`NCT04572841` - Safety, Tolerability, Pharmacokinetics, and Therapeutic Efficacy of SAR441344 in Primary Sjögren's Syndrome (pSjS)	Phase 2
Completed	`NCT04111341` - A Clinical Trial to Evaluate the Safety and Efficacy of Traditional Chinese Medicine in Sjögren's Syndrome.	Phase 2
Recruiting	`NCT03060005` - Is Sjögren's Syndrome Associated With Meibomian Gland Dysfunction ?	N/A
Terminated	`NCT01316770` - Dexamethasone Irrigation of the Parotid Glands in Primary Sjögren's Syndrome Subjects	Phase 2
Completed	`NCT02422407` - A Longitudinal, Observational Biomarker Study in Participants With Primary Sjogren's Syndrome	N/A
Completed	`NCT01160666` - Efficacy and Safety of Belimumab in Subjects With Primary Sjögren's Syndrome	Phase 2
Active, not recruiting	`NCT02849093` - Optical Coherence Tomography of Ocular Structures in Epiphora and Dry Eye Syndrome.	N/A
Active, not recruiting	`NCT02112019` - Endoscopic Treatment of Salivary Glands Affected by Sjögren's Syndrome	N/A
Recruiting	`NCT03983408` - Impact of Korean Red Ginseng on Fatigue in Patients With Rheumatic Disease	N/A
Completed	`NCT00873496` - Effects of Hydroxychloroquine on Oral Complaints of Sjögren Patients	N/A
Completed	`NCT05680064` - The Effect of Chewing Gum, Exercises of the Tongue, Lip, Jaw on Salivation, Xerostomia, Dysphagia in Sjögren's Syndrome	N/A
Recruiting	`NCT02110446` - Evaluation of the Efficacy and the Mechanism of Chinese Herbal Formula SS-1 for Sjögren's Syndrome	Phase 2
Recruiting	`NCT02855658` - Modulation of Immunity-related Gene Expression Under the Chinese Herbal Formula SS-1 Treatment for Sjögren's Syndrome	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.