Integrated Diagnostics for Early Diagnosis of Liver Disease

Sponsor
Manchester University NHS Foundation Trust
Study ID
NCT04666402
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Blood tests for Single Nucleotide Polymorphisms — OTHER
    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.
  • Faecal microbiome analysis — DIAGNOSTIC_TEST
    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.
  • Serum for diagnostic biomarkers — DIAGNOSTIC_TEST
    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.

Study Details

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.

Key Dates

First listed
Dec 14, 2020
Start date
Oct 21, 2020
Status verified
Feb 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
1,200 participants (estimated)

Primary Outcome Measure

Reduction in patient numbers requiring secondary care appointments for the investigation of advanced liver fibrosis. [ Time Frame: At study completion; within 3 years ]

Central Contacts

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