Integrated Diagnostics for Early Diagnosis of Liver Disease

Summary

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.

Conditions

• Non-Alcoholic Fatty Liver Disease
• Non-alcoholic Steatohepatitis
• Alcoholic Liver Disease
• Liver Fibroses

Interventions

OTHER

Blood tests for Single Nucleotide Polymorphisms

This 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.

DIAGNOSTIC_TEST

Faecal microbiome analysis

This 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.

DIAGNOSTIC_TEST

Serum for diagnostic biomarkers

Blood 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.

Sponsors & Collaborators

• University of Manchester

  collaborator OTHER

• University of Nottingham

  collaborator OTHER

• Innovate UK

  collaborator OTHER_GOV

• Manchester University NHS Foundation Trust

  lead OTHER_GOV

Principal Investigators

• Varinder Athwal · Manchester University NHS Foundation Trust/Manchester University

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-10-21

Primary Completion

2027-03-31

Completion

2027-03-31

Countries

• United Kingdom

Study Locations