STOP-HCV Cirrhosis Study
Research type
Research Study
Full title
Prognostic biomarkers in HCV cirrhosis.
IRAS ID
150126
Contact name
Neil Guha
Contact email
Sponsor organisation
Nottingham University Hospitals NHS Trust
Research summary
Cirrhosis of the liver is a distinct condition resulting from long term liver disease, specifically scarring of the liver (fibrosis). The progression from fibrosis to cirrhosis is broadly divided into 2 phases: compensated (largely symptom free) and decompensated (classically associated with fluid collections in the abdomen, bleeding from liver veins and jaundice). The transition from compensation to decompensation represents a landmark in the progression of the disease with markedly different survival times for each.
Significant complications in cirrhosis as a result of chronic HCV infection have been reported to be between 20-30% at 5 years in a number of observational studies. Studies have shown that if compensated cirrhosis is classified by disease severity then information predicting symptoms (prognostic information) is improved.
Whilst it is generally accepted that current scoring systems are useful in classifying severe disease (as exemplified by which patients should be listed for liver transplantation) there may be potential to improve upon this using new diagnostic tests in the blood or urine (non-invasive biomarkers); particularly in earlier compensated cirrhosis.
The availability of novel biomarkers potentially allows better classification of prognostic information. A number of studies have shown that biomarkers at baseline predict liver related events 5-10 years later across a range of liver diseases. However liver disease is a dynamic process which suggests that the serial measurement of biomarkers would be better.
It is hoped that this study will give greater insight into whether serial measurement of biomarkers, measured on an annual basis, can be used to predict which patients with compensated HCV cirrhosis develop a clinical outcome within 5 years of follow up. Identification of patients at higher risk of disease progression will translate into enhanced clinical management of those patients, particularly with respect to the development of liver cancer.
REC name
West Midlands - Black Country Research Ethics Committee
REC reference
14/WM/1128
Date of REC Opinion
2 Sep 2014
REC opinion
Favourable Opinion