Active not recruitingOBSERVATIONAL

Paediatric Sjögren Syndrome Cohort Study and Repository (PaedSSCoRe)

This research is about Sjögren's syndrome (SS) in children and teenagers (under 18) across the UK. In adults, SS often causes dry eyes and mouth, but it can affect other parts of the body too. We don't know much about how SS affects children, and it might be more common than we think. This study aims to collect important health information, such as symptoms and test results, from young people with SS. The goal is to better understand the condition's impact on children and create clearer ways to diagnose it. This will help doctors provide better care and support for young patients with SS.

At a glance

Status

Active not recruiting

Sponsor

University College, London

Enrolment target

300

Start

11 Jan 2020

Estimated completion

10 Jan 2030

Sjogren's Syndrome Childhood-onset

What is this study about?

Sjögren's syndrome (SS) is a condition that mostly affects adults, causing things like very dry eyes and a very dry mouth. This happens because the body's immune system, which normally fights off germs, mistakenly attacks glands that produce moisture. Sometimes, SS can also affect other parts of the body, not just the eyes and mouth. When someone has SS on its own, it's called primary SS. If they have it alongside another long-term health condition, it's called secondary SS.

While we know a fair bit about SS in adults, we don't know much about how it affects children and teenagers (under 18). Doctors believe it's quite rare in young people, but it's also possible that it's just not recognised or diagnosed as often as it should be. Because of this, there haven't been many studies looking at how many children have SS or how it affects them specifically.

This important study, called PaedSSCoRe, aims to fill these gaps. Researchers want to gather information from children and teenagers with SS across many hospitals in the UK. They will look at different things like their age, symptoms, and results from various tests. By collecting all this information, the study hopes to create better ways for doctors to identify and diagnose SS in children. Ultimately, understanding more about childhood SS will help improve the care and support available for young patients.

Key takeaways

This study focuses on Sjögren's syndrome in children and teenagers.
It aims to better understand how the condition affects young people in the UK.
Participation involves sharing routine health information from hospital visits.
There are no new treatments or medications involved in this study.
The goal is to improve diagnosis and future care for children with Sjögren's syndrome.
You can withdraw from the study at any time without affecting your child's care.

Who may be eligible?

To join this study, a child must have received a diagnosis of Sjögren's syndrome (SS) from their doctor before their 18th birthday. This diagnosis can be for SS on its own or if it's linked to another long-term health condition. Even if a child hasn't been officially diagnosed but their doctor strongly suspects SS based on their symptoms or test results, they might still be able to join.

Children need to be at least 6 years old to take part. Also, either the young person themselves (if old enough to understand) or their parent/carer must be able to agree to take part. This includes agreeing to let the doctors use information from their routine hospital visits for the study.

Unfortunately, if a child or their parent/carer cannot give their permission to join the study, then they won't be able to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is my child under 18 years old?
Has a doctor mentioned that my child might have Sjögren's syndrome?
Is my child at least 6 years old?
Am I (or is my child if old enough) able to understand and agree to take part?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the medical team will collect information about your child's health from their usual hospital appointments. This includes details like their age, their symptoms, and the results of various tests like blood tests, scans, or gland biopsies taken as part of their routine care. From time to time, typically every 6 months, and if your child has an increase in their symptoms (a 'flare-up'), the research team will also collect information on how the disease is affecting them and how they feel about their health. They might also collect extra samples like blood, tears, saliva, or urine if they are available and with your permission. There are no new medications given as part of this study, as it focuses on observing patients who are already receiving standard care. Your participation will continue for as long as your child is being followed up for their Sjögren's syndrome, with data collected at regular intervals.

Potential risks and benefits

Taking part in this study won't change your child's medical treatment; they will continue to receive the standard care from their doctors. The main benefit is that the information gathered will help doctors learn more about Sjögren's syndrome in children, leading to better ways to diagnose and treat it in the future for other young patients. There are very few risks associated with this study, as it mainly involves collecting information from routine appointments and, if agreed, samples that might already be taken. You can choose to stop taking part in the study at any time without it affecting your child's medical care.

Locations (8)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Children's Health Ireland (CHI) at Crumlin
Verified postcode
Dublin, Ireland
Cambridge University Hospitals NHS Foundation Trust
Verified postcode
Cambridge, United Kingdom
Great Ormond Street Hospital For Children NHS Foundation Trust
Verified postcode
London, United Kingdom
University College London Hospital
Verified postcode
London, United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Verified postcode
Newcastle, United Kingdom
Sheffield Children's NHS Foundation Trust
Verified postcode
Sheffield, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Verified postcode
Sheffield, United Kingdom
University Hospital Southampton NHS Foundation Trust
Verified postcode
Southampton, United Kingdom

Common questions

What is Sjögren's syndrome?

It's a condition where the body's immune system attacks glands that produce moisture, often leading to dry eyes and mouth. It can also affect other parts of the body.

Why is this study important for children?

We don't know much about Sjögren's syndrome in children. This study aims to gather information to help doctors understand and diagnose it better in young people.

Will my child receive new medicines or treatments?

No, this study only collects information from your child's regular medical care. They will continue to receive their usual treatment.

What kind of information will be collected?

Doctors will collect details about your child's symptoms, test results, and how the condition affects them, using information from their routine hospital visits.

Can I change my mind about participating?

Yes, you or your child can choose to stop taking part in the study at any time, and it will not affect their medical care.