NAFLDNCT04442334
The European NAFLD Registry
An observational study of NAFLD and NASH, run by Newcastle University at 37 sites in 12 countries.
Trial summary
The European NAFLD Registry is a prospectively recruited, observational study supporting the study of the clinical phenotype, natural history, disease outcomes and pathophysiology of Non-Alcoholic Fatty Liver Disease and Non-Alcoholic Steatohepatitis. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- NAFLD, NASH, NASH - Nonalcoholic Steatohepatitis
- How many people
- 10,000 participants
- Where
- 37 sitesin 12 countries
- Study dates
- 1 May 2015to 31 Dec 2030
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with a pre-existing liver biopsy providing histological evidence of NAFLD or, patients undergoing liver biopsy for suspected NAFLD with biochemical and/or radiological findings consistent with NAFLD, or patients with radiological evidence of cirrhosis (in absence of an alternative aetiology) plus presence of ≥2 features indicative of the 'metabolic syndrome'.
Who may be able to join
- Age ≥18 years.
- Clinically suspected NAFLD based on any of:
- Patient with historical liver biopsy providing histological evidence of NAFLD or,
- Patient undergoing liver biopsy for suspected NAFLD with biochemical and/or radiological findings consistent with NAFLD or,
- Patient with radiological evidence of cirrhosis (in absence of an alternative aetiology) plus presence of ≥2 features indicative of the 'metabolic syndrome':
- Increased waist circumference by ethnically adjusted criteria (e.g. Europid male/female ≥94cm/80cm) or overweight/obese (BMI ≥25);
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- Raised fasting glucose ≥100 mg/dL [5.6 mmol/L], HbA1c ≥48mmol/mol (6.5%) or previously diagnosed insulin resistance/type 2 diabetes mellitus (or on treatment);
- Dyslipidaemia (fasting TG level ≥150 mg/dL [1.7 mmol/L]; or fasting HDL <40 mg/dL [1.03 mmol/L] in males and <50 mg/dL [1.29 mmol/L] in females; or on treatment);
- Hypertension (systolic BP ≥130 or diastolic BP ≥85 mmHg, or on treatment).
- Average alcohol consumption less than 21/14 units/week (males/females) in preceding 6 months and no history of sustained excessive consumption of alcohol in past 5 years.
Who cannot join
- Refusal or inability (lack of capacity) to give informed consent.
- Average alcohol ingestion greater than approximately 21/14 units/week (males/females) in preceding 6 months or history of sustained excessive consumption of alcohol in past 5 years.
- History or presence of Type 1 diabetes mellitus.
- Presence of any other form of chronic liver disease except NAFLD.
- Recent (within 12 months) or concomitant use of agents known to cause hepatic steatosis (long-term systemic corticosteroids [>10 days], amiodarone, methotrexate, tamoxifen, tetracycline, high dose oestrogens, valproic acid).
- Any contra-indication to liver biopsy.
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- Recent (within 3 months) change in dose/regimen or introduction of Vitamin E (at a dose ≥400 IU/day), betaine, s-adenosyl methionine, ursodeoxycholic acid, silymarin or pentoxifylline.
- Non-English speaking/unable to access an interpreter. Due to the nature of the study, English language or access to a relevant interpreter is a necessary criterion to ensure lifestyle (diet and exercise) and symptom data are collated.
- Patients not meeting inclusion criteria or judged by the investigator to be unsuitable for inclusion in the study.
Trial locations and contacts
37 sites in 12 countries. Contact the study team or a site near you to ask about taking part.
37 sites in 12 countries
United Kingdom11 sites, 11 recruiting
- Recruiting
University Hospitals Birmingham Nhs Foundation Trust
Birmingham
Philip Newsome, MBChB, PhD, P.N.Newsome@bham.ac.uk
Philip Newsome, MBChB, PhD
- Recruiting
Addenbrooke'S Hospital
Cambridge
Michael Allison, MBBS, PhD, michael.allison@addenbrookes.nhs.uk
Mike Allison, MBBS, PhD
- Not yet recruiting
Queen Elizabeth Hospital
Gateshead
Dina Mansour, MA, MBBS, dina.mansour@nhs.net
Dina Mansour, MA, MBBS
- Recruiting
Hull Royal Infirmary
Hull
Lynsey Corless, MBChB, PhD, lynsey.corless@hey.nhs.uk
Lynsey Corless, MBChB, PhD
- Recruiting
Royal London Hospital, Barts Health NHS Trust
London
William Alazawi, MBBC, PhD, w.alazawi@nhs.net
William Alazawi, MBBC, PhD
- Recruiting
St George's University Hospitals
London
Metin Devrim, MSc, MBBS, MetinDevrim.Yalcin@stgeorges.nhs.uk
Metin Devrim, MSc, MBBS
- Recruiting
The Newcastle Upon Tyne Hospitals Nhs Foundation Trust
Newcastle upon Tyne, NE7 7DN
Quentin M Anstee, MBBS, PhD, quentin.anstee@ncl.ac.uk
Quentin M Anstee, MBBS, PhD
- Recruiting
Queen'S Medical Centre
Nottingham
Guru Aithal, MD, PhD, Guru.Aithal@nuh.nhs.uk
Guru Aithal, MD, PhD
- Recruiting
Oxford University Hospitals Nhs Foundation Trust
Oxford
Jeremy Cobbold, MBBS MA PhD, Jeremy.Cobbold@ouh.nhs.uk
Jeremy Cobbold, MBBS MA PhD
- Recruiting
Derriford Hospital
Plymouth
David Sheridan, MBBS, PhD, david.sheridan2@nhs.net
David Sheridan, MBBS, PhD
- Recruiting
Queen Alexandra Hospital
Portsmouth
Joanna Dowman, MBChB, PhD, Joanna.Dowman@porthosp.nhs.uk
Joanna Dowman, MBChB, PhD
Spain6 sites, 6 recruiting
- Recruiting
Vall d'Hebron University Hospital
Barcelona
Salva Augustin, MD, salva.augustin@gmail.com
Salva Augustin, MD
- Recruiting
Biodonostia Health Research Institute
Donostia / San Sebastian
Jesus Banales, PhD, Jesus.banales@biodonostia.org
Jesus Banales, PhD
- Recruiting
Puerta de Hierro University Hospital
Majadahonda
Joseluis Calleja, MD, Joseluis.calleja@uam.es
Joseluis Calleja, MD
- Recruiting
Marqués de Valdecilla University Hospital
Santander
Javier Crespo, MD, Javiercrespo1991@gmail.com
Javier Crespo, MD
- Recruiting
Institute of Biomedicine of Sevilla (IBiS), Virgen del Rocío University Hospital
Seville
Manuel Romero-Gomez, MD, mromerogomez@us.es
Manuel Romero-Gomez, MD
- Recruiting
HU Clínico de Valladolid
Valladolid
Rocío Aller de la Fuente, MD, PhD, rallerf@saludcastillayleon.es
Rocío Aller de la Fuente, MD, PhD
Germany5 sites, 5 recruiting
- Not yet recruiting
UNIVERSITÄTSKLINIKUM der RWTH Aachen
Aachen, 52074
Christian Trautwein, MD, ctrautwein@ukaachen.de
Christian Trautwein, MD
- Not yet recruiting
Charité University Hospital Berlin
Berlin
Muenevver Demir, MD, muenevver.demir@charite.de
Muenevver Demir, MD
- Not yet recruiting
Universitätsklinikum Freiburg
Freiburg im Breisgau, 79106
Rafael Kaeser, DrMed, +49 761 270-35500, rafael.kaeser@uniklinik-freiburg-.de
Rafael Kaeser, DrMed
- Recruiting
UNIVERSITÄTSMEDIZIN der Johannes Gutenberg Universität Mainz
Mainz, 55131
Jörn M Schattenberg, DrMed, +49 (0) 6131 176074, joern.schattenberg@unimedizin-mainz.de
Jörn M Schattenberg, DrMed
- Recruiting
Universitätsklinikums Würzburg
Würzburg, D-97080
Andreas Geier, MD, Geier_A2@ukw.de
Andreas Geier, MD
Italy5 sites, 5 recruiting
- Recruiting
Polytechnic University of Marche
Ancona
Gianluca Svegliati-Baroni, MD, gsvegliati@gmail.com
Gianluca Svegliati-Baroni, MD
- Recruiting
Università degli Studi Milano
Milan
Luca Valenti, MD, luca.valenti@unimi.it
Luca Valenti, MD
- Recruiting
Università di Palermo
Palermo
Salvatore Petta, MD, PhD, petta.salvatore@unipa.it
Salvatore Petta, MD, PhD
- Recruiting
Università Cattolica del Sacro Cuore
Rome
Luca Miele, MD, PhD, luca.miele@policlinicogemelli.it
Luca Miele, MD, PhD
- Recruiting
Department of Medical Sciences University of Torino
Turin
Elisabetta Bugianesi, MD, PhD, elisabetta.bugianesi@unito.it
Elisabetta Bugianesi, MD, PhD
France2 sites, 2 recruiting
- Recruiting
Le Centre de Recherche Clinique (CRC) du CHU d'Angers
Angers, 49933
Jerome Boursier, MD, PhD, JeBoursier@chu-angers.fr
Jerome Boursier, MD, PhD
- Recruiting
Institut ICAN - Institute of Cardiometabolism And Nutrition Hôpital de la Pitié Salpêtrière
Paris, 75013
Vlad Ratzu, MD, vlad.ratziu@inserm.fr
Vlad Ratzu, MD
Sweden2 sites, 2 recruiting
- Recruiting
Karolinska Universitetssjukhuset
Huddinge
Hannes Hagstrom, MD, hannes.hagstrom@ki.se
Hannes Hagstrom, MD
- Recruiting
Linköping University Hospital
Linköping
Mattias Ekstedt, MD, mattias.ekstedt@liu.se
Mattias Ekstedt, MD
Belgium1 site, 1 recruiting
- Recruiting
Universitair Ziekenhuis Antwerpen
Antwerp
Sven M Francque, MD, PhD, +3238214572, Sven.Francque@uza.be
Sven M Francque, MD, PhD
Finland1 site, 1 recruiting
- Recruiting
Helsinki University Hospital
Helsinki
Hannele Yki-Järvinen, MD, Hannele.Yki-Jarvinen@helsinki.fi
Hannele Yki-Järvinen, MD
Greece1 site, 1 recruiting
- Recruiting
Laiko General Hospital of Athens
Athens, 11527
Gergios Papatheodoridis, MD, PhD, gepapath@med.uoa.gr
Gergios Papatheodoridis, MD, PhD
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC
Amsterdam
A G Holleboom, MD, PhD, a.g.holleboom@amsterdamumc.nl
A G Holleboom, MD, PhD
Portugal1 site, 1 recruiting
- Recruiting
Hospital de Santa Maria
Lisbon
Helena Cortez-Pinto, MD, PhD, hlcortezpinto@netcabo.pt
Helena Cortez-Pinto, MD, PhD
Switzerland1 site, 1 recruiting
- Recruiting
Inselspital, University Hospital
Bern
Jean-Francois Dufour, MD, PhD, Jean-Francois.Dufour@insel.ch
Jean-Francois Dufour, MD, PhD
About this study
The European NAFLD Registry is a prospectively recruited, observational study supporting the study of the clinical phenotype, natural history, disease outcomes and pathophysiology of Non-Alcoholic Fatty Liver Disease and Non-Alcoholic Steatohepatitis. The ultimate goals are to better understand the drivers of interpatient variation in disease pathophysiology and severity and to utilise this information to develop and validate biomarkers that, singly or in combination, enable detection and monitoring of disease progression and/or from NAFL through NASH to fibrosis and cirrhosis.
Read the detailed description
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.
- Conditions
- NAFLD, NASH, NASH - Nonalcoholic Steatohepatitis, Fibrosis, Liver, Steatosis of Liver, Hepatocellular Carcinoma
- Keywords
- NAFLD, NASH, Steatohepatitis, Liver, Cirrhosis, Non-alcoholic fatty liver disease
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Liver Cirrhosis, Fatty Liver, Carcinoma, Hepatocellular, Cardiovascular Diseases, Diabetes Mellitus, Type 2, Dyslipidemias, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detailed Characterisation of the NAFLD Patient Phenotype
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.
Measured: 1 day
Secondary outcomes (6)
Disease Natural History
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.
Measured: Through to study completion, an average of 5 years
Lifestyle factors: Dietary Habits
Cross-sectional and longitudinal study of dietary habits in patients with NAFLD using: Mediterranean Diet Score.
Measured: Through study completion, an average of 5 years
Lifestyle factors: Activity/Exercise
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).
Measured: Through study completion, an average of 5 years
Health Related Quality of Life: CLDQ
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).
Measured: Through study completion, an average of 5 years
Health Related Quality of Life: EQ5D5L
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
Measured: Through study completion, an average of 5 years
Health Related Quality of Life: NASH-CHECK
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.
Measured: Through study completion, an average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start1 May 2015
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NAFLDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Newcastle University
- Sponsor type
- University, hospital or other
- Collaborators
- Newcastle-upon-Tyne Hospitals NHS Trust, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Institute of Cardiometabolism and Nutrition, France, University of Cambridge, Örebro University, Sweden, University of Bern, University of Oxford, University of Turin, Italy, Angers University, University Hospital, Antwerp, Linkoeping University, University of Helsinki, UMC Utrecht, National and Kapodistrian University of Athens, University of Lisbon, University of Milan, University of Palermo, Catholic University of the Sacred Heart, Wuerzburg University Hospital, RWTH Aachen University, University of Nottingham, Medical University of Vienna, University of Birmingham, University of Florence, Assistance Publique - Hôpitaux de Paris, University Medical Center Mainz
- Responsible party
- Sponsor
- Investigators
- Quentin M Anstee, MBBS, PhD, Principal investigator, Newcastle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04442334
- Sponsor's protocol ID
- 08759
- Other IDs
- 634413, 777377
- Status last verified
- Jan 2023
- First submitted
- 12 May 2020
- Last updated
- 6 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McGlinchey AJ, Govaere O, Geng D, Ratziu V, Allison M, Bousier J, Petta S, de Oliviera C, Bugianesi E, Schattenberg JM, Daly AK, Hyotylainen T, Anstee QM, Oresic M. Metabolic signatures across the full spectrum of non-alcoholic fatty liver disease. JHEP Rep. 2022 Mar 26;4(5):100477. doi: 10.1016/j.jhepr.2022.100477. eCollection 2022 May.
PubMed 35434590
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The European NAFLD Registry
- ClinicalTrials.gov ID
- NCT04442334
- Acronym / sponsor ID
- 08759
- Conditions
- NAFLD, NASH, NASH - Nonalcoholic Steatohepatitis, Fibrosis, Liver, Steatosis of Liver, Hepatocellular Carcinoma
- Keywords
- NAFLD, NASH, Steatohepatitis, Liver, Cirrhosis, Non-alcoholic fatty liver disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Newcastle UniversityUniversity, hospital or other
- Collaborators
- Newcastle-upon-Tyne Hospitals NHS Trust, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Institute of Cardiometabolism and Nutrition, France, University of Cambridge, Örebro University, Sweden, University of Bern, University of Oxford, University of Turin, Italy, Angers University, University Hospital, Antwerp, Linkoeping University, University of Helsinki, UMC Utrecht, National and Kapodistrian University of Athens, University of Lisbon, University of Milan, University of Palermo, Catholic University of the Sacred Heart, Wuerzburg University Hospital, RWTH Aachen University, University of Nottingham, Medical University of Vienna, University of Birmingham, University of Florence, Assistance Publique - Hôpitaux de Paris, University Medical Center Mainz
- Study start
- 1 May 2015 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 22 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The European NAFLD Registry is a prospectively recruited, observational study supporting the study of the clinical phenotype, natural history, disease outcomes and pathophysiology of Non-Alcoholic Fatty Liver Disease and Non-Alcoholic Steatohepatitis. The ultimate goals are to better understand the drivers of interpatient variation in disease pathophysiology and severity and to utilise this information to develop and validate biomarkers that, singly or in combination, enable detection and monitoring of disease progression and/or from NAFL through NASH to fibrosis and cirrhosis.
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with a pre-existing liver biopsy providing histological evidence of NAFLD or, patients undergoing liver biopsy for suspected NAFLD with biochemical and/or radiological findings consistent with NAFLD, or patients with radiological evidence of cirrhosis (in absence of an alternative aetiology) plus presence of ≥2 features indicative of the 'metabolic syndrome'.
Key inclusion criteria (10 listed)
- Age ≥18 years.
- Clinically suspected NAFLD based on any of:
- Average alcohol consumption less than 21/14 units/week (males/females) in preceding 6 months and no history of sustained excessive consumption of alcohol in past 5 years.
Key exclusion criteria (9 listed)
- Refusal or inability (lack of capacity) to give informed consent.
- Average alcohol ingestion greater than approximately 21/14 units/week (males/females) in preceding 6 months or history of sustained excessive consumption of alcohol in past 5 years.
- History or presence of Type 1 diabetes mellitus.
- Presence of any other form of chronic liver disease except NAFLD.
- Recent (within 12 months) or concomitant use of agents known to cause hepatic steatosis (long-term systemic corticosteroids [>10 days], amiodarone, methotrexate, tamoxifen, tetracycline, high dose oestrogens, valproic acid).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
6 secondary outcomes
Disease Natural History
Time frame: Through to study completion, an average of 5 years
Lifestyle factors: Dietary Habits
Time frame: Through study completion, an average of 5 years
Lifestyle factors: Activity/Exercise
Time frame: Through study completion, an average of 5 years
Health Related Quality of Life: CLDQ
Time frame: Through study completion, an average of 5 years
Health Related Quality of Life: EQ5D5L
Time frame: Through study completion, an average of 5 years
Health Related Quality of Life: NASH-CHECK
Time frame: Through study completion, an average of 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2023.
- Derived from this study: PubMed 35434590McGlinchey AJ, Govaere O, Geng D, Ratziu V, Allison M, Bousier J, Petta S, de Oliviera C, Bugianesi E, Schattenberg JM, Daly AK, Hyotylainen T, Anstee QM, Oresic M. Metabolic signatures across the full spectrum of non-alcoholic fatty liver disease. JHEP Rep. 2022 Mar 26;4(5):100477. doi: 10.1016/j.jhepr.2022.100477. eCollection 2022 May.
- Individual participant dataSharing planned: No
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Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Quentin M Anstee, MBBS, PhD principal investigator
Newcastle University
37 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NAFLD and NASH, run by Newcastle University at 37 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United Kingdom, Spain, Germany, Italy, France and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Quentin M Anstee, MBBS, PhD (+44(0)191 20 87012, quentin.anstee@ncl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detailed Characterisation of the NAFLD Patient Phenotype (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04442334, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2023.