Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01807689 · ClinicalTrials.gov registry record
Salivary Biomarkers for Sjögren's Syndrome Detection
A clinical trial, sponsored by University of California, Los Angeles.
- Completed
- Registry status
- 420
- Enrollment target
NCT01807689: Completed study, sponsored by University of California, Los Angeles.
NCT01807689 is a clinical trial that has completed, run by University of California, Los Angeles. The registered enrollment target is 420 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01807689 has completed, sponsored by University of California, Los Angeles.
- COMPLETED
- Registry status
- 420 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 420 participants |
| Start Date | 2013-04-01 |
| Est. Completion | 2018-09-01 |
What the finished NCT01807689 record still lists
NCT01807689 is an observational study that tracks outcomes without assigning an intervention. The registered 420 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01807689 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01807689 about?
NCT01807689 is a clinical study titled "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 Americ...
What is the current status of trial NCT01807689?
This trial is currently completed. The enrollment target is 420 participants. The study started on 2013-04-01. Estimated completion is 2018-09-01.
Who is sponsoring clinical trial NCT01807689?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01790152 · 420 participants
Effects of Dexrazoxane Hydrochloride on Biomarkers Associated With Cardiomyopathy and Heart Failure After Cancer Treatment
- NCT02701244 · 420 participants
A Registry Study of Breast Microseed Treatment
- NCT02966665 · 420 participants · Phase 1
: Vascular Function in Health and Disease
- NCT04149743 · 420 participants · NA
HEMOTAG® Assessment for Short-term Outcomes of Heart Failure
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI