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JOURNAL ONKOLOGIE – STUDIE

The European NAFLD Registry

Rekrutierend

NCT-Nummer:
NCT04442334

Studienbeginn:
Mai 2015

Letztes Update:
08.10.2020

Wirkstoff:
-

Indikation (Clinical Trials):
Carcinoma, Hepatocellular, Fatty Liver, Non-alcoholic Fatty Liver Disease, Liver Cirrhosis, Dyslipidemias, Cardiovascular Diseases

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Newcastle University

Collaborator:
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, Univers

Studienleiter

Quentin M Anstee, MBBS, PhD
Principal Investigator
Newcastle University

Kontakt

Studienlocations
(3 von 37)

Universitätsklinikum Freiburg
79106 Freiburg
(Baden-Württemberg)
GermanyNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Rafael Kaeser, DrMed
Phone: +49 761 270-35500
E-Mail: rafael.kaeser@uniklinik-freiburg-.de
» Ansprechpartner anzeigen
UNIVERSITÄTSMEDIZIN der Johannes Gutenberg Universität Mainz
55131 Mainz
(Rheinland-Pfalz)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Jörn M Schattenberg, DrMed
Phone: +49 (0) 6131 176074
E-Mail: joern.schattenberg@unimedizin-mainz.de
» Ansprechpartner anzeigen
Pankreaskrebszentrum des Universitätsklinikums Würzburg
Josef-Schneider-Straße 2
97080 Würzburg
DeutschlandRekrutierend» Google-Maps
Ansprechpartner:
Andreas Geier, MD
E-Mail: Geier_A2@ukw.de
» Ansprechpartner anzeigen
Institut ICAN - Institute of Cardiometabolism And Nutrition Hôpital de la Pitié Salpêtrière
75013 Paris
FranceRekrutierend» Google-Maps
Ansprechpartner:
Vlad Ratzu, MD
E-Mail: vlad.ratziu@inserm.fr
» Ansprechpartner anzeigen
The Newcastle Upon Tyne Hospitals Nhs Foundation Trust
NE7 7DN Newcastle-upon Tyne
United KingdomRekrutierend» Google-Maps
Ansprechpartner:
Quentin M Anstee, MBBS, PhD
E-Mail: quentin.anstee@ncl.ac.uk
» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

Inclusion Criteria:

1. Age ≥18 years.

2. Clinically suspected NAFLD based on any of:

1. Patient with historical liver biopsy providing histological evidence of NAFLD or,

2. Patient undergoing liver biopsy for suspected NAFLD with biochemical and/or radiological findings consistent with NAFLD or,

3. 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);

- 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).

3. 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.

Exclusion Criteria

1. Refusal or inability (lack of capacity) to give informed consent.

2. 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.

3. History or presence of Type 1 diabetes mellitus.

4. Presence of any other form of chronic liver disease except NAFLD.

5. 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).

6. Any contra-indication to liver biopsy.

7. 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.

8. 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.

9. Patients not meeting inclusion criteria or judged by the investigator to be unsuitable for inclusion in the study.

Studien-Rationale

Primary outcome:

1. 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.



Secondary outcome:

1. 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.

2. 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.

3. 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).

4. 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).

5. 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

6. 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.

Studien-Arme

  • 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.

Quelle: ClinicalTrials.gov


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