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Role of Innate Lymphoid Cells in primary SJÖgren*s syndrome salivary gland damage

Role of Innate Lymphoid Cells in primary SJÖgren*s syndrome salivary gland damage - ILCSJO

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON45875
Enrollment
90
Registered
2019-01-30
Start date
2019-04-11
Completion date
Unknown
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Can a special type of early immune cells trigger loss of saliva production in Sjögren's syndrome?

Interventions

None listed

Sponsors

ReumaNederland,
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

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

MeasureTime 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

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Aug 15, 2026