What role do immune cells have in the development and persistence of Sjögren's syndrome?

Completed

Conditions: (primary) Sjögren's syndrome
sicca syndrome
10003816

Registration Number: NL-OMON33948

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 400

Inclusion Criteria

Group 1: Patients (>= 18 yr) with sicca complaints, with a suspicion of Sjögren's syndrome, and that will undergo lipbiopsy as a diagnostic tool
Group 2: Patients (>= 18 yr), who are diagnosed with Sjögren's syndrome, according to the revised American-European consensus group (Vitali, Bombardieri et al. 2002), with a lymphocytic focus score >=1 on minor salivary gland biopsy. Patients (>= 18 yr), who are diagnosed with non-Sjögren's sicca syndrome, with a lymphocytic focus score of 0 on minor salivary gland biopsy.
Healthy controls (>= 18 yr), recruited from the Minidonordienst (inhouse blood donating service) of the UMC Utrecht, who are free of the use of immunosuppressive drugs.

Exclusion Criteria

Patients with any other causes of dryness will not be included in this study. Individuals that are not free of the use of immunosuppressive drugs at least 3 months prior to this study.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary immunological parameters:<br /><br><br /><br>1. activation of several types of immune cells before and after stimulation<br /><br>with and without blockade of this stimulation (read-out measurements:<br /><br>proliferation, activation markers, cytokine production and other inflammatory<br /><br>mediators)<br /><br>2. cytokine en biomarker profiles in serum and saliva.<br /><br><br /><br>These parameters will be compared between Sjögren patiënts, non-Sjögren sicca<br /><br>patients, and healthy controls as outcome measurements.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>These parameters will be compared between Sjögren patiënts and non-Sjögren<br /><br>sicca patients as outcome measurements.<br /><br><br /><br>3. General disease parameters, which will be measured during their annual visit<br /><br>to the outpatient clinic of the UMC Utrecht. (e.g. immunoglobulines, ESR,<br /><br>leukocyte count).<br /><br>4. unstimulated and stimulated salivary flow<br /><br>5. unstimulated tear production<br /><br>6. brief impression of general fatigue symptoms, and subjective dryness of<br /><br>mouth and eyes with the use of questionnaires</p><br>