NCT04762108: PaedSSCoRe

Paediatric Sjögren Syndrome Cohort Study and Repository (PaedSSCoRe)

Active, enrolled Last updated 19 April 2021

What this trial tests

trial testing Standard of care in Sjogren's Syndrome Childhood-onset in 300 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

11 January 2020

Primary endpoint
10 January 2030

10 January 2030

Quick facts

Lead sponsor	University College, London
Status	Active, enrolled
Study type	OBSERVATIONAL
Enrollment	300
Start date	11 January 2020
Primary completion	10 January 2030
Estimated completion	10 January 2030
Sites	8 locations across United Kingdom, Ireland

Drugs / interventions tested

• Standard of care

Conditions studied

• Sjogren's Syndrome Childhood-onset — all drugs for Sjogren's Syndrome Childhood-onset →

Sponsor

University College, London

Who can join

6 and older, any sex, with Sjogren's Syndrome Childhood-onset. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Sjögren syndrome (SS) in adults is characterised by inflammation of the exocrine glands, principally the salivary and lacrimal glands resulting in xerostomia (dry mouth) and xerophthalmia (dry eyes).It can also present with more extensive exocrinopathy as well as extra-glandular, systemic features.

SS is defined as primary SS (pSS) when it occurs in isolation, and as secondary SS, if associated with other autoimmune conditions. The incidence and prevalence rates of SS vary depending on the population. To date, there have been no studies reporting accurate incidence or prevalence of SS in childhood. Childhood onset SS defined as disease diagnosed before 18 years of age is believed to be rare; however, it is likely it is under-recognised and therefore under-diagnosed.

The overarching aim of this study is to identify epidemiological, clinical and laboratory characteristics of paediatric SS in a United Kingdom (UK) multi-centre cohort of patients. Using this data our goal is to develop universally accepted classification criteria that could be validated for use in a paediatric population.

Inclusion criterion for the study and repository is a diagnosis of SS made before 18 years by the referring physician. A data collection pack will be sent to authors willing to participate. Information collected will include but not exclusive to: demographic, clinical and laboratory/histological data at diagnosis and subsequent follow-up appointments. Biological samples including blood, tears, saliva, urine and glandular and extra-glandular (e.g. renal) tissue will be collected prospectively if available. Outcome measures related to disease activity and damage, as well as patient reported outcomes will also be collected at set time points (every 6 months) and during flares.

PaedSSCoRe will capture data on a significant cohort of children with SS providing a powerful resource to help improve our understanding of the pathogenesis and natural course of this disease.

Prospective data collection will allow a fuller analysis of poor prognostic features, impact of therapy and damage accrual, and variable outcome of childhood SS.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.