Role of Innate Lymphoid Cells in primary SJÖgren*s syndrome salivary gland damage
- Conditions
- Can a special type of early immune cells trigger loss of saliva production in Sjögren's syndrome?10003816
- Registration Number
- NL-OMON45875
- Lead Sponsor
- ReumaNederland,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 90
In order to be eligible to participate in this study, a subject in the Sjogren*s syndrome work-up traject must meet all of the following criteria:;• Presents with subjective dry mouth symptoms.
• Willing to have exam of oral cavity and a parotid biopsy.
• Scheduled for parotid biopsy for routine diagnosis and care.
Further classification into non-Sjogren*s syndrome sicca (for example induced through medication), early pSS or pSS, performed based on the decision tree and associated clinical parameters in Figure 1.
A potential subject who meets any of the following criteria will be excluded from participation in this study:
• History of radiation therapy to the head or neck.
• Another auto-immune disease, lymphoma, sarcoidosis, hepatitis C, IgG4 disease, HIV (all exclusion criteria for classifying a subject as pSS).
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>: For the patient, the harvesting of a parotid gland biopsy represents the<br /><br>endpoint of the activities involved in the ILCSJO study. No further<br /><br>interventions or samples from the patient are required. The biopsy will be<br /><br>harvested during a routine biopsy procedure as part of the diagnostic work-up.</p><br>
- Secondary Outcome Measures
Name Time Method <p>N/A</p><br>