The European NAFLD Registry
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|ClinicalTrials.gov Identifier: NCT04442334|
Recruitment Status : Recruiting
First Posted : June 22, 2020
Last Update Posted : January 6, 2023
|Condition or disease|
|NAFLD NASH NASH - Nonalcoholic Steatohepatitis Fibrosis, Liver Steatosis of Liver Hepatocellular Carcinoma Cardiovascular Diseases Type 2 Diabetes Dyslipidaemia Hypertension Obesity Other Associated Comorbidities|
The European NAFLD Registry is a major international collaboration between clinical academics at leading universities across Europe, initially established with funding from the European Association for the Study of the Liver and through the EU FP7, H2020 and IMI2 schemes to the projects FLIP (Fatty Liver Inhibition of Progression), EPoS (Elucidating Pathways of Steatohepatitis) and LITMUS (Liver Investigation: Testing marker Utility in Steatohepatitis).
The Registry is a non-interventional, observational study collecting cross-sectional and longitudinal clinical data (including clinical biochemistry/haematology, liver histology, comorbidities, prescribed medication and imaging data) and linked biological samples (Blood [Serum, Plasma], Liver Tissue, Urine, Stool) from prospectively recruited patients with NAFLD. Its purpose is to support clinical and translational research into disease pathophysiology (through development of comprehensive genetic, epigenetic, transcriptomic, metabolomic, proteomic and metagenomic datasets) and biomarker development/validation. It supports collaborative discovery science and serves as the basis for a broad international project to discover and validate biomarkers for NAFLD and associated medical conditions (LITMUS). Out-with the current study, following separate ethical approval and after separate consent, patients who have agreed to join the European NAFLD Registry may also agree to participate in a number of nested sub-studies with bi-directional sharing of data. These include the LITMUS Imaging Study, which will acquire additional imaging data across a range of modalities including, amongst others, MR-PDFF and MR-Elastography. The Registry population comprises adult patients (aged ≥18 years) with risk factors for non-alcoholic fatty liver disease (NAFLD) prospectively recruited primarily in hepatology and diabetology clinics and/or bariatric surgery units at centres across Europe. After receiving informed consent, patients will be assigned a unique study identifier (which will be used to identify all data and samples collected) which will allow all information to be recorded in a link-anonymised form.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||10000 participants|
|Target Follow-Up Duration:||10 Years|
|Official Title:||The European NAFLD Registry|
|Actual Study Start Date :||May 1, 2015|
|Estimated Primary Completion Date :||December 31, 2030|
|Estimated Study Completion Date :||December 31, 2030|
The LITMUS Study Cohort
Prospectively recruited NAFLD patients, recruited according to The European NAFLD Registry study protocol.
The LITMUS Metacohort
Collated data and biological samples on patients with histologically characterised NAFLD prospectively recruited at contributing academic centres across Europe.
EFPIA Clinical Trial Cohort
Collated data and biological samples on patients with histologically characterised NAFLD that have participated in phase 2 and phase 3 trials of IMPs for NAFLD.
- Detailed Characterisation of the NAFLD Patient Phenotype [ Time Frame: 1 day ]Prospective patient recruitment and collection of cross-sectional clinical data is undertaken (including clinical biochemistry/haematology, liver histology, comorbidities, prescribed medication and imaging data).These data will be used to determine number of participants exhibiting specific features of NAFLD/NASH disease severity at enrolment including: histological grade of disease and fibrosis stage (assessed using the well validated NASH Clinical Research Network "NAFLD Activity Score" [NAS] and the FLIP "Steatosis - Activity - Fibrosis" [SAF] systems), frequency of common metabolic comorbidities (eg type 2 diabetes mellitus, dyslipidaemia, cardiovascular disease), and associated changes in clinical biochemistry/haematology/imaging parameters. Biological samples to support clinical and translational research into disease pathophysiology (e.g. genetic, epigenetic, transcriptomic, metabolomic, proteomic and metagenomic datasets) and biomarker development/validation will be collected.
- Disease Natural History [ Time Frame: Through to study completion, an average of 5 years ]
Longitudinal follow-up of patients with NAFLD by annual review to characterise disease natural history and determine number of participants experiencing clinically significant events including the occurrence and timing of incident comorbidities and key target conditions of interest such as:
- Death (cause of death)
- Major Adverse Cardiovascular Events (MACE)
- Hepatic (e.g. diagnosis of cirrhosis, hepatic decompensation, hepatocellular carcinoma, transplantation)
- Other (diagnosis of extra-hepatic malignancy/emergency hospitalisation)
Routine clinical data generated as part of standard care will be collected annually. Clinical parameters assessed for changes indicative of alteration in disease state during follow-up include: clinical biochemistry/haematology, liver histology, comorbidities, prescribed medication and imaging data. Biological samples to support translational research into disease pathophysiology and biomarker development/validation will also be collected.
- Lifestyle factors: Dietary Habits [ Time Frame: Through study completion, an average of 5 years ]Cross-sectional and longitudinal study of dietary habits in patients with NAFLD using: Mediterranean Diet Score.
- Lifestyle factors: Activity/Exercise [ Time Frame: Through study completion, an average of 5 years ]Cross-sectional and longitudinal study of lifestyle factors (e.g. activity/sedentary behaviour/exercise levels) in patients with NAFLD using: International Physical Activity Questionnaire (IPAQ).
- Health Related Quality of Life: CLDQ [ Time Frame: Through study completion, an average of 5 years ]Cross-sectional and longitudinal collection of standardised data on HRQOL and symptom burden in patients with NAFLD using Patient Reported Outcome Measure (PROM): Chronic Liver Disease Questionnaire for NAFLD NASH (CLDQ NAFLD-NASH).
- Health Related Quality of Life: EQ5D5L [ Time Frame: Through study completion, an average of 5 years ]Cross-sectional and longitudinal collection of standardised data on HRQOL and symptom burden in patients with NAFLD using Patient Reported Outcome Measure (PROM): EQ-5D-5L Health
- Health Related Quality of Life: NASH-CHECK [ Time Frame: Through study completion, an average of 5 years ]Cross-sectional and longitudinal collection of standardised data on HRQOL and symptom burden in patients with NAFLD using Patient Reported Outcome Measure (PROM): NASH-CHECK.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04442334
|Contact: Quentin M Anstee, MBBS, PhD||+44(0)191 20 firstname.lastname@example.org|
|Contact: Kristy L Wonders, BA, MLitt||+44(0)191 email@example.com|
|Principal Investigator:||Quentin M Anstee, MBBS, PhD||Newcastle University|