Actively Recruiting
European Paediatric Non-Alcoholic Fatty Liver Disease Registry (EU-PNAFLD)
Led by Cambridge University Hospitals NHS Foundation Trust · Updated on 2022-03-04
2000
Participants Needed
3
Research Sites
1563 weeks
Total Duration
On this page
Sponsors
C
Cambridge University Hospitals NHS Foundation Trust
Lead Sponsor
T
The European Association for the Study of the Liver
Collaborating Sponsor
AI-Summary
What this Trial Is About
The EU-PNAFLD (The European Paediatric NALFD Registry) will be a network composed of European centres involved in the care of children with NAFLD, and will include Hepatologists, Endocrinologists, and Scientists, supported by relevant international specialists. This collaboration will build on existing infrastructure (local databases and bio-repositories) and will align with the adult European NAFLD Registry ("EPoS", Elucidating Pathways of Steatohepatitis study) to allow long-term follow-up supported by translational studies. Through an international, well-characterised large-scale cohort, we hope to: facilitate multi-centre clinical trials; extend our understanding of the key disease mechanisms of NAFLD; and establish the natural history of paediatric NAFLD.
CONDITIONS
Official Title
European Paediatric Non-Alcoholic Fatty Liver Disease Registry (EU-PNAFLD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis made under 18 years of age
- Diagnosis of NAFLD spectrum disease including simple steatosis, steatosis with abnormal transaminases, NASH with or without fibrosis or cirrhosis
- Radiological evidence of hepatic steatosis (e.g., increased liver echogenicity on ultrasound)
- Exclusion of secondary causes by negative liver screening tests (HBV/HCV), normal caeruloplasmin (>0.20g/L), no excess alcohol use, no iron overload, and no significant alpha-1 antitrypsin phenotype (SZ, ZZ, SS)
- Diagnosis may be supported by liver histology showing >5% steatosis consistent with pediatric NAFLD
You will not qualify if you...
- Secondary fatty liver diseases such as glycogen storage diseases, Wilson disease, viral hepatitis, drug-related liver disease, autoimmune hepatitis, or type 1 diabetes mellitus
- Post-transplant fatty liver disease
- Alcohol intake greater than 20 grams per day
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Maastricht UMC
Maastricht, Netherlands
Active, Not Recruiting
2
Addenbrooke's Hospital
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Actively Recruiting
3
Birmingham Children's Hospital
Birmingham, United Kingdom
Actively Recruiting
Research Team
J
Jake P Mann, MRCPCH
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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