REgistry of Pediatric Sjögren syndrome in Umcg- LongiTudinal (REPSULT)
Recruiting
- Conditions
- Sjogren syndrome10003816
- Registration Number
- NL-OMON49266
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
Confirmed or probable SS diagnosed before the age of 17 years.
Exclusion Criteria
Subjects who are impaired or incapable of completing cohort-related assessments
Serious comorbidity or laboratory abnormalities that, in the opinion of the
investigator, unacceptably increase the burden or risk of participation in the
cohort.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Aims:<br /><br>1. Define disease presentation of children with SS-like complaints<br /><br>2. Evaluate current adult classification criteria in pedSS patients<br /><br>3. Analyze the genetic constitution of pedSS<br /><br>4. Assess essential biomarkers (of adult SS) in children with SS<br /><br>5. Analyze and describe the clinical course and HRQoL of pedSS<br /><br>6. Identify predictors of MALT lymphoma in pedSS<br /><br><br /><br>Parameters<br /><br>Clinical and patient-reported parameters, salivary and tear gland function,<br /><br>ultrasound and histopathology of salivary glands, laboratory parameters,<br /><br>immunological parameters in serum, saliva and tears, and genetic markers. </p><br>
- Secondary Outcome Measures
Name Time Method <p>na</p><br>