Stratification Of LIver Disease (SOLID)
Research type
Research Study
Full title
Stratification Of LIver Disease (SOLID): Determining the optimum biomarker strategies for the detection of advanced liver disease at the primary-secondary care interface
IRAS ID
310086
Contact name
Stuart McPherson
Contact email
Sponsor organisation
The Newcastle upon Tyne Hospitals NHS Foundation Trust
ISRCTN Number
ISRCTN31148824
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Undiagnosed significant liver disease is highly prevalent in the community, primarily due to high rates of harmful alcohol consumption and obesity. Obesity and harmful alcohol consumption cause fatty liver disease, which can progress to cirrhosis and complications including liver cancer and liver failure. Because liver disease is usually asymptomatic at early stages, patients frequently present once advanced liver disease has developed when they are at high risk of complications. Early identification of liver disease before cirrhosis and earlier initiation of lifestyle changes and treatment may prevent progression to cirrhosis.
The overall aim of this study is to develop an effective primary care fibrosis biomarker pathway to identify patients with advanced liver fibrosis in individuals with risk factors for liver disease. The study will use a clinical care pathway that incorporates a ‘liver assessment’ within primary care annual chronic disease reviews to identify patients with significant liver disease. This pathway will be a platform to evaluate the performance of non-invasive liver fibrosis biomarkers.
In the pathway, individuals with obesity, Type 2 diabetes or harmful alcohol consumption will have a ‘liver assessment’ using established non-invasive fibrosis biomarkers including FIB-4, ELF and transient elastography (TE; Fibroscan). Blood samples will be taken for novel biomarkers, including ProC3, to evaluate their performance. Individuals with suspected significant/advanced liver fibrosis (TE>8 kPa), will be reviewed in a secondary care liver clinic to confirm their stage of liver fibrosis and institute specific treatment and/or enhanced lifestyle management within routine NHS clinical services. This pathway will allow us to evaluate the diagnostic accuracy of the FIB-4, ELF and ProC3 alone or in combination, as well as collect samples to assess future novel blood-based biomarkers of liver disease. Patients will also be followed longitudinally via their electronic health records and NHS digital to assess long-term clinical outcomes.
REC name
London - Chelsea Research Ethics Committee
REC reference
22/PR/0535
Date of REC Opinion
28 Jun 2022
REC opinion
Further Information Favourable Opinion