NCT04442334Recrutement en cours
The European NAFLD Registry
Résumé
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.
Critères d'inclusion
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.
Critères d'exclusion
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.
Contacts
Les coordonnées de l'équipe de l'essai s'affichent sur demande.
Voir la fiche officielle de l'essai- Statut
- Recrutement en cours
- Phase
- —
- Type d'étude
- Observationnelle
- Pays
- Suisse, France, Allemagne, Italie, Belgique, Finlande, Grèce, Pays-Bas, Portugal, Espagne, Suède, Royaume-Uni
- Promoteur
- Newcastle University(Autre)
- N° de protocole
- 08759
- Pathologies
- NAFLD, NASH, NASH - Nonalcoholic Steatohepatitis, Fibrosis, Liver, Steatosis of Liver, Hepatocellular Carcinoma, Cardiovascular Diseases, Type 2 Diabetes, Dyslipidaemia, Hypertension, Obesity, Other Associated Comorbidities
- Interventions
- —
Collaborateurs
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
Lieux · 33
- Bern, SuisseInselspital, University HospitalRecrute dans ce centre
- Angers, FranceLe Centre de Recherche Clinique (CRC) du CHU d'AngersRecrute dans ce centre
- Paris, FranceInstitut ICAN - Institute of Cardiometabolism And Nutrition Hôpital de la Pitié SalpêtrièreRecrute dans ce centre
- Mainz, AllemagneUNIVERSITÄTSMEDIZIN der Johannes Gutenberg Universität MainzRecrute dans ce centre
- Würzburg, AllemagneUniversitätsklinikums WürzburgRecrute dans ce centre
- Ancona, ItaliePolytechnic University of MarcheRecrute dans ce centre
- Milan, ItalieUniversità degli Studi MilanoRecrute dans ce centre
- Palermo, ItalieUniversità di PalermoRecrute dans ce centre
- Rome, ItalieUniversità Cattolica del Sacro CuoreRecrute dans ce centre
- Turin, ItalieDepartment of Medical Sciences University of TorinoRecrute dans ce centre
- Antwerp, BelgiqueUniversitair Ziekenhuis AntwerpenRecrute dans ce centre
- Helsinki, FinlandeHelsinki University HospitalRecrute dans ce centre
- Athens, GrèceLaiko General Hospital of AthensRecrute dans ce centre
- Amsterdam, Pays-BasAmsterdam UMCRecrute dans ce centre
- Lisbon, PortugalHospital de Santa MariaRecrute dans ce centre
- Barcelona, EspagneVall d'Hebron University HospitalRecrute dans ce centre
- Donostia / San Sebastian, EspagneBiodonostia Health Research InstituteRecrute dans ce centre
- Majadahonda, EspagnePuerta de Hierro University HospitalRecrute dans ce centre
- Santander, EspagneMarqués de Valdecilla University HospitalRecrute dans ce centre
- Seville, EspagneInstitute of Biomedicine of Sevilla (IBiS), Virgen del Rocío University HospitalRecrute dans ce centre
- Valladolid, EspagneHU Clínico de ValladolidRecrute dans ce centre
- Huddinge, SuèdeKarolinska UniversitetssjukhusetRecrute dans ce centre
- Linköping, SuèdeLinköping University HospitalRecrute dans ce centre
- Birmingham, Royaume-UniUniversity Hospitals Birmingham Nhs Foundation TrustRecrute dans ce centre
- Cambridge, Royaume-UniAddenbrooke'S HospitalRecrute dans ce centre
- Hull, Royaume-UniHull Royal InfirmaryRecrute dans ce centre
- London, Royaume-UniRoyal London Hospital, Barts Health NHS TrustRecrute dans ce centre
- London, Royaume-UniSt George's University HospitalsRecrute dans ce centre
- Newcastle upon Tyne, Royaume-UniThe Newcastle Upon Tyne Hospitals Nhs Foundation TrustRecrute dans ce centre
- Nottingham, Royaume-UniQueen'S Medical CentreRecrute dans ce centre
Au total, dans le monde, 33 des 37 centres listés au registre recrutent ; les 4 autres ne recrutent pas actuellement.
Statut par centre selon le registre ClinicalTrials.gov (dernière mise à jour publiée : 6 janvier 2023).
Ce statut peut avoir changé et ne dit rien de votre éligibilité : avant toute démarche, vérifiez avec votre oncologue ou le centre.
+ 3 autres lieux
Autres identifiants
- 634413 · autre financement
- 777377 · autre financement
Voir aussi
Autres versions
Ces résultats sont indicatifs et ne remplacent pas un avis médical — à discuter avec votre médecin.