NCT04190849Recruiting
European Paediatric Non-Alcoholic Fatty Liver Disease Registry (EU-PNAFLD)
The European Paediatric Non-alcoholic Fatty Liver Disease Registry (EU-PNAFLD): a Prospective, Longitudinal Follow-up of Children With Non-alcoholic Fatty Liver Disease
Source: ClinicalTrials.gov · Last updated 4 Mar 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 2000 (estimated)
- First submitted
- 5 Dec 2019
- Start date
- 14 Nov 2017
- Primary completion date
- 30 Nov 2047
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Diseases
- Fatty liver disease (MASLD/MASH), Liver and biliary tract cancer, Childhood cancers, Type 2 diabetes
- NCT number
- NCT04190849
What you commit to
- Study type: Observational
- Planned participants: 2000
- From 14 Nov 2017 to the primary completion date, 30 Nov 2047
- 3 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Post-transplant fatty liver
Other illness
- Secondary fatty liver disease (e.g. glycogen storage diseases, Wilson disease, viral hepatitis, drug-related, autoimmune hepatitis, type 1 diabetes mellitus)
Other
- \>20g/day ethanol intake
Who the study is looking for
- Diagnosis made under 18 years of age.
- Diagnosis of NAFLD spectrum disease (simple steatosis (NAFL), steatosis with abnormal transaminases, NASH ± fibrosis or cirrhosis)
- Diagnosis established by:
- Radiological evidence of hepatic steatosis (e.g. increased hepatic echogenicity on ultrasound), with
- Exclusion of secondary causes (negative serological liver screen for HBV/HCV, caeruloplasmin \>0.20g/L, no history of excess alcohol consumption, no evidence of iron overload, and no clinically significant alpha-1 antitrypsin (A1AT) phenotype (i.e. SZ, ZZ, SS), with or without
- Histology (\>5% steatosis and histology consistent with paediatric NAFLD)
Age in the registry: - to 18 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Birmingham Children's Hospital Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Recruiting |
| Addenbrooke's Hospital Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Recruiting |
| Maastricht UMC Coordinator of this site? Confirm its status | Maastricht | Netherlands | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.