European Registry for Adults with Non-Alcoholic Fatty Liver Disease and Non-Alcoholic Steatohepatitis Observational Study Collecting Clinical Data and Biological Samples to Understand Disease Progression and Biomarker Development

What this Trial Is About

Researchers are studying Non-Alcoholic Fatty Liver Disease NAFLD and Non-Alcoholic Steatohepatitis NASH through the European NAFLD Registry, an observational study aimed at understanding how the disease varies among patients, its natural progression, and underlying causes. The study focuses on identifying and validating biomarkers that can help detect and monitor disease progression from NAFL through NASH to fibrosis and cirrhosis. This international collaboration involves major European universities and ongoing projects funded by European health initiatives. The study collects detailed clinical data and biological samples from adult patients suspected of having NAFLD. Data includes clinical biochemistry, liver histology, imaging, medication use, and comorbidities. Biological samples include blood, liver tissue, urine, and stool. Participants are recruited primarily from hepatology, diabetology clinics, and bariatric surgery units across Europe. The registry also supports nested sub-studies with additional imaging and data collection, such as MR-PDFF and MR-Elastography, under separate consent. Participants provide informed consent and are assigned unique identifiers to protect privacy. The study involves detailed characterization of the NAFLD patient phenotype in a single day, with follow-up over an average of five years to track disease natural history, lifestyle factors like diet and exercise, and health-related quality of life using various assessment tools. Data collection and monitoring support collaborative research and biomarker development to improve understanding and management of NAFLD and related conditions.

The European NAFLD Registry