Can a special type of early immune cells trigger loss of saliva production in Sjögren's syndrome?
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| : For the patient, the harvesting of a parotid gland biopsy represents the endpoint of the activities involved in the ILCSJO study. No further interventions or samples from the patient are required. The biopsy will be harvested during a routine biopsy procedure as part of the diagnostic work-up. | — |
Countries
Netherlands