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RECRUITINGOBSERVATIONAL

Integrated Diagnostics for Early Diagnosis of Liver Disease

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - All patients referred to Community Liver Assessment Clinic. - Male or female \> 18 years of age. - Females will be non-pregnant and non-lactating. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * All patients referred to Community Liver Assessment Clinic. * Male or female \> 18 years of age. * Females will be non-pregnant and non-lactating. Exclusion Criteria: * 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.

Treatments Being Tested

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.

Locations (1)

Manchester University NHS Foundation Trust
Manchester, Greater Manchester, United Kingdom