EVenti
Research type
Research Study
Full title
The Prognostic Performance of the Enhanced Liver Fibrosis Test in UK Patients with Chronic Liver Disease Assessed 20 Years After Recruitment to the EUROGOLF study.
IRAS ID
264286
Contact name
William Rosenberg
Contact email
Clinicaltrials.gov Identifier
125496, Sponsor Ref.Number
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
Approximately 29 million people in Europe suffer from a chronic liver condition, with 0.1% already affected by cirrhosis. Globally, cirrhosis is the eleventh cause of mortality, and third cause of death in middle-aged men in the UK. Chronic liver disease causes liver injury leading to progressive liver fibrosis that may results in cirrhosis, portal hypertension and complications, including bleeding varices, ascites, hepatic encephalopathy and liver failure. Furthermore, cirrhosis increases the risk of hepatocellular carcinoma, the third cause of cancer-related death.
The Enhanced Liver Fibrosis (ELF) Test was discovered and validated in a 1,000 patients recruited between 1998 and 2000 as a non-invasive serum test combining measurements of three blood markers of liver fibrosis in an algorithm to generate a unitless score that quantifies liver fibrosis.
Between 2007-9 the original EUROGOLF investigators gained permission from MREC to obtain ONS death certificates and interrogate hospital records and general practice records of the 457 participants recruited in the UK for the original study without the need to go back and seek permission from individual patients on the grounds of difficulty in tracing the participants. 61 events were recorded at the 7 years census point including 39 deaths.
The EVenti study aims to evaluate the long-term predictive clinical value of the ELF test by following up the patients participating at the original European Liver Fibrosis study in English centers.
With help from the Confidentiality Advisory Service we are requesting a legal basis to hold the confidential patient information in order to enable us to apply for data held by NHS Digital regarding liver-related morbidity and mortality, at 20 years after inclusion in the original cohort to determine the long-term prognostic performance of ELF. All patients included in the original study in English centers will be eligible for inclusion.REC name
London - Stanmore Research Ethics Committee
REC reference
20/LO/0347
Date of REC Opinion
23 Apr 2020
REC opinion
Further Information Favourable Opinion