Salivary Biomarkers for Sjögren's Syndrome Detection

This study is not yet open for participant recruitment.
Verified March 2013 by University of California, Los Angeles
Sponsor:
Collaborators:
Oklahoma Medical Research Foundation
University of Minnesota - Clinical and Translational Science Institute
University Medical Centre Groningen
Information provided by (Responsible Party):
David Wong, DMD, MDSc, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01807689
First received: February 21, 2013
Last updated: March 6, 2013
Last verified: March 2013
  Purpose

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.


Condition
Sjögren's Syndrome

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Salivary Biomarkers for Sjögren's Syndrome Detection - A Multi-Center Study

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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

Saliva


Estimated Enrollment: 420
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)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

All enrolled subjects must be classified as having both oral and ocular sicca symptoms, without another autoimmune/connective tissue disease. All enrolled subjects, who are also being evaluated as part of their clinical care, using the standard diagnostic tests of the AECG criteria of 2002, will meet the ARC criteria.

Criteria

Inclusion Criteria:

  • Ability to give informed consent (Appendix 1).
  • Male or female patients 18 years of age or older.
  • Patients with sicca symptoms as defined in Appendix 2.
  • Must be willing to have a standard physical exam as part of standard clinical care and a complete diagnostic work-up according to the new ACR criteria for ocular staining, labial salivary gland biopsy and serology.
  • Must be willing to have a standard physical exam and complete AECG diagnostic tests as part of standard clinical care (including eye exam, oral exam, salivary gland exam and biopsy).
  • Must be willing to complete a questionnaire (approximately 10 min).
  • Must be willing to donate 1ml of stimulated, whole saliva in 30 minutes or less. If a participant cannot produce 1ml during a 30 min collection period, subject will be unevaluable and will be considered a screen failure and withdrawn from the study.
  • For UMCG only, subject must be willing to have a labial salivary gland biopsy in addition to a parotid biopsy.
  • Must be willing and able to give approximately 8ml of blood.
  • Must be willing to be tested for Hepatitis C, if required

Exclusion Criteria:

  • Previous radiation to the head and neck.
  • Confirmed hepatitis C virus infection, which may cause SS-like signs and symptoms.
  • Known HIV infection, which can cause salivary gland infiltrates and enlargements similar to SS.
  • Sarcoidosis, which may cause SS-like signs and symptoms.
  • Graft-versus-host disease, which may cause SS-like signs and symptoms.
  • Oral cancer or history of oral cancer.
  • Pregnancy based on self-report.
  • Previously diagnosed with pSS or sSS using AECG criteria or SS using ACR criteria.
  • Previously confirmed diagnosis of autoimmune disease known to be associated with Secondary Sjögren's syndrome (sSS) (rheumatoid arthritis (RA), systemic lupus erythematosus (SLE)), CREST (Calcinosis, Raynaud's syndrome, Esophageal dysmotility, Sclerodactyly, Telangiectasia), Scleroderma, Mixed connective tissue disease, Polymyositis.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01807689

Contacts
Contact: David Wong, DMD, MDSc 310-206-3048 dtww@ucla.edu
Contact: David Akin 310-825-9792 dakin@dentistry.ucla.edu

Locations
United States, California
UCLA - School of Dentistry Not yet recruiting
Los Angeles, California, United States, 90095
Contact: David Wong, DMD, DMSc    310-206-3048    dtww@ucla.edu   
Contact: David Akin    310-825-9792    dakin@dentistry.ucla.edu   
Sub-Investigator: Nelson Rhodus, DMD, MPH         
Sub-Investigator: Arjan Vissink, DMD, MD, PhD         
Sub-Investigator: Hal Scofield, MD         
Sponsors and Collaborators
University of California, Los Angeles
Oklahoma Medical Research Foundation
University of Minnesota - Clinical and Translational Science Institute
University Medical Centre Groningen
Investigators
Principal Investigator: David Wong, DMD, MDSc University of California, Los Angeles
  More Information

No publications provided

Responsible Party: David Wong, DMD, MDSc, Assoc. Dean of Research, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01807689     History of Changes
Other Study ID Numbers: SS Biomarker Development Study
Study First Received: February 21, 2013
Last Updated: March 6, 2013
Health Authority: United States: Institutional Review Board
Denmark: Ethics Committee

Keywords provided by University of California, Los Angeles:
Dry mouth
Dry eyes
Saliva
Salivary gland biopsy

Additional relevant MeSH terms:
Sjogren's Syndrome
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014