RecruitingNCT04666402

Integrated Diagnostics for Early Diagnosis of Liver Disease

Sponsor

Manchester University NHS Foundation Trust

Enrollment

1,200 participants

Start Date

Oct 21, 2020

Study Type

OBSERVATIONAL

Conditions

Non-Alcoholic Fatty 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.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

All patients referred to Community Liver Assessment Clinic.
Male or female > 18 years of age.
Females will be non-pregnant and non-lactating.

Exclusion Criteria6

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.
Acutely unwell.
Suspected malignancy.

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Interventions

OTHERBlood 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_TESTFaecal 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_TESTSerum 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.