Sjögren's SyndromeNCT01807689
Salivary Biomarkers for Sjögren's Syndrome Detection
An observational study of Sjögren's Syndrome, run by University of California, Los Angeles at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sjögren's Syndrome
- How many people
- 420 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2013to 1 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
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- 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produce 1ml during a 30 min collection period, subject will be unevaluable and will be considered a screen failure and withdrawn from the study.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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA - School of Dentistry
Los Angeles, California, 90095
About this study
Official title: Salivary Biomarkers for Sjögren's Syndrome Detection - A Multi-Center Study
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.
Read the 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.
- Conditions
- Sjögren's Syndrome
- Keywords
- Dry mouth, Dry eyes, Saliva, Salivary gland biopsy
- Medical subject headings
- Sjogren's Syndrome, Xerostomia, Dry Eye Syndromes
What is being measured
The primary outcome is the main question the study is designed to answer.
With a PRoBE design, build an initial collective salivary biomarker panel to evaluate its ability to diagnose a Sjogrenn Syndrome (SS) patient.
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.
Measured: First 210 subjects up to 24 months.
Secondary outcomes (1)
Test the second 210 recruited subjects, refine and evaluate the collective saliva biomarker panel on entire 420 subjects.
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.
Measured: Full 420 subjects within 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2013 (estimated)
- Study start1 Apr 2013
- Primary completion1 Aug 2018
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjögren's SyndromeStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Oklahoma Medical Research Foundation, University Medical Center Groningen
- Responsible party
- Principal investigator, David Wong, DMD, MDSc, University of California, Los Angeles
- Investigators
- David Wong, DMD, MDSc, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01807689
- Sponsor's protocol ID
- SS Biomarker Development Study
- Status last verified
- Apr 2019
- First submitted
- 21 Feb 2013
- Last updated
- 19 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salivary Biomarkers for Sjögren's Syndrome Detection - A Multi-Center Study
- ClinicalTrials.gov ID
- NCT01807689
- Acronym / sponsor ID
- SS Biomarker Development Study
- Conditions
- Sjögren's Syndrome
- Keywords
- Dry mouth, Dry eyes, Saliva, Salivary gland biopsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Oklahoma Medical Research Foundation, University Medical Center Groningen
- Study start
- 1 Apr 2013 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 8 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- 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).
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Wong, DMD, MDSc principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sjögren's Syndrome, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2019.