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NCT01807689

Salivary Biomarkers for Sjögren's Syndrome Detection

Completed Last updated 19 April 2019
What this trial tests

trial in Sjögren's Syndrome in 420 participants. Completed in 1 September 2018.

Timeline
1 April 2013
Primary endpoint
1 August 2018
1 September 2018

Quick facts

Lead sponsorUniversity of California, Los Angeles
StatusCompleted
Study typeOBSERVATIONAL
Enrollment420
Start date1 April 2013
Primary completion1 August 2018
Estimated completion1 September 2018
Sites1 location across United States

Conditions studied

Sponsor

University of California, Los Angeles

Who can join

18 and older, any sex, with Sjögren's Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Sjögren's Syndrome

Currently open trials in the same condition.

Other University of California, Los Angeles trials

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Data sources for this page

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