This is an observational study that will explore the hypothesis that by combining data from patients with liver disease with novel blood biomarkers, single nucleotide polymorphism (SNP) analysis and faecal microbiome analysis. The Investigators will improve diagnosis of liver fibrosis compared to the current available diagnostic tools.
All patients referred to Community Liver Assessment Clinic.
Male or female > 18 years of age.
Females will be non-pregnant and non-lactating.
Age < 18 years.
Pregnancy/breast-feeding. Women of childbearing potential (not >2 years post- menopausal and/or not surgically sterilised) must have a negative blood serum pregnancy test.
Isolated bilirubinaemia.
Known pre-existing liver disease.
Patients attending Community Liver Assessment Clinic within Manchester with deranged liver function tests, fatty liver on ultrasound or a history of alcohol excess
Cohort
Prospective
Blood tests for Single Nucleotide Polymorphisms
Other interventionThis extra test would be performed on participants assessed in the specialist liver clinic. This test would require an extra 5ml of blood to be taken at the time of routine blood tests for clinical purposes.
Faecal microbiome analysis
Diagnostic testThis test will be undertaken for all participants who give consent and are assessed through the new liver care pathway, in the community liver assessment clinic. All participants will be given the equipment to take a stool sample at the time of presentation at the community liver assessment clinic and asked to return the sample to the clinic. The sample will be processed to remove genetic material so the microbiome can be identified.
Serum for diagnostic biomarkers
Diagnostic testBlood samples will be taken alongside blood taken for clinical assessment. In total, an extra 5ml of blood. These samples will be used to explore novel blood biomarkers using ELISA and mass-spectroscopy techniques in the University of Manchester.
Reduction in patient numbers requiring secondary care appointments for the investigation of advanced liver fibrosis.
Our project aims to identify patients with liver fibrosis in the community and only those with evidence of advanced fibrosis or cirrhosis being triaged on into secondary care hepatology services.
To define the metrics involved in the diagnosis of advanced liver fibrosis or cirrhosis
Through combining the data from basic clinical bloods such as LFTs, non-invasive scoring systems such as FIB-4 and NAFLD fibrosis scores along with the novel biomarkers, we will use this data through AI to develop algorithms that will aid the diagnosis of advanced fibrosis/cirrhosis.
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Manchester University NHS Foundation Trust
Lead sponsor
University of Manchester
Collaborator
University of Nottingham
Collaborator
Innovate UK
Collaborator
