Actively Recruiting

Age: 0 - 18Years
All Genders
NCT04190849

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

Age: 0 - 18Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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