Predictive Biomarkers in NAFLD and HCC
Research type
Research Study
Full title
Deciphering Immunometabolic pathways for disease progression in Non-Alcoholic Fatty Liver Disease (NAFLD) and hepatocellular carcinoma (HCC)
IRAS ID
268996
Contact name
Saima Ajaz
Contact email
Sponsor organisation
King's College Hospital NHS Foundation Trust
Duration of Study in the UK
0 years, 11 months, 30 days
Research summary
According to figures released by NHS Digital in May 2019, there is a 15 per cent increase in hospital admissions because of fat-related conditions. Non-alcoholic fatty liver disease (NAFLD) is the fastest growing health problem globally; driven by rising levels of obesity. The spectrum of NAFLD ranges from accumulation of simple fat around the liver also known as steatosis to an inflammatory phase defined as Non-alcoholic steatohepatitis (NASH). Subsequently, this process can lead to scarring to the liver and can progress to cirrhosis (serious scarring of the liver), and even liver cancer (called "hepatocellular carcinoma" (HCC)).
Liver biopsy is currently the "gold standard" diagnostic test for NASH. There is an urgent need to identify non-invasive biomarkers (a measurable indicator of the seriousness or presence of disease); not only for early detection of patients with NASH, but which could also predict the progression of fibrosis (stiffening of the liver) with the disease. Defects in energy production and changes in metabolites (biological breakdown products) form the basis of this disease. The aim of the study is to investigate mitochondrial dysfunction and metabolite changes in patients with NASH and HCC to identify mechanistic biomarkers.
This is a cross-sectional study, intending to recruit 130 participants in 4 different cohorts. Blood samples will be taken at one time point in all subjects. Biopsy samples will be obtained from 30 participants from cohorts 2-4 as outlined in protocol.
Metabolic profiling will be done with Liquid chromatography–mass spectrometry (LC-MS) and Gas chromatography-mass spectrometry (GC-MS), aiming to investigate the changes in metabolites in plasma and liver tissues of the patients with different stages of fibrosis in NASH and in HCC for identifying signature biomarkers.
REC name
London - Chelsea Research Ethics Committee
REC reference
21/LO/0581
Date of REC Opinion
29 Jul 2021
REC opinion
Further Information Favourable Opinion