Salivary biomarkers for primary Sjögren's syndrome detection. A multi-center study. (Biomarker development study)

Completed

Conditions: Sjögren's syndrome
10003816

Registration Number: NL-OMON39480

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 120

Inclusion Criteria

• Subjects greater than or equal to age 18 years of age.
• Subjects must have sicca symptoms, i.e. subjective dry mouth (xerostomia) and dry eyes (keratoconjunctivitis sicca, xeropthalmia) to be enrolled.
• Subjects willing to fill out questionnaire (approximately 10 min).
• Subjects should be willing to donate saliva.
• Subjects should be willing to have a labial biopsy in addition to a parotid biopsy.
• Subjects should be willing and able to give approximately 8 ml of blood.
(for details see pages 15-16 of the protocol)

Exclusion Criteria

• Previous radiation to the head and neck (with exception of radioactive iodine for thyoid ablation therapy).
• 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.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>This research project will test the hypothesis that there are salivary<br /><br>constituents that are biomarkers that can differentiate SS from non-SS sicca<br /><br>subjects as defined by ACR. Specifically, a biomarker panel could be<br /><br>constructed that has specificity significantly higher than 25% for non-SS<br /><br>patients at a threshold corresponding to 95% sensitivity for SS patients. This<br /><br>panel will be built in Aim 1, to be then tested and refined in Aim 2. If<br /><br>confirmed, it will be fixed for a future independent biomarker validation<br /><br>study.</p><br>

Secondary Outcome Measures