Skip to main content
UK clinical trials - updated daily from ClinicalTrials.gov
TrialConnect
← Back to Search
Looking for participantsN/A

Integrated Diagnostics for Early Diagnosis of Liver Disease

Sponsor: Manchester University NHS Foundation Trust

NCT ID: NCT04666402

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Blood tests for Single Nucleotide Polymorphisms (other), Faecal microbiome analysis (diagnostic test), Serum for diagnostic biomarkers (diagnostic test)
How long the study runs
Study runs about 77 months (dates as stated)
About the drug or intervention
Blood tests for Single Nucleotide Polymorphisms — other: This extra test would be performed on participants assessed in the specialist liver clinic. · 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. · Serum for diagnostic biomarkers — diagnostic test: Blood samples will be taken alongside blood taken for clinical assessment.
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
18 Years and over
Who
All
Number of participants
1,200
Started
2020-10-21
Last checked
2026-02

Plain English Summary

What is this study?

  • • Testing a new treatment for non-alcoholic fatty liver disease
  • • Clinical study - 1,200 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with non-alcoholic fatty liver disease

Where?

  • • Manchester - Manchester University NHS Foundation Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

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.

More detail

Liver disease is a silent epidemic. Four in ten people in the North West are likely to have evidence of liver disease. A small but significant proportion of these patients develop scarring, leading to end-stage cirrhosis. All too frequently this is detected in very advanced stages, where treatment cannot reverse the condition. It is one of the UK's largest health challenges. At present clinicians use a wide range of single tests that individually struggle to identify disease and high-risk patients early. The Investigators are implementing a new pathway for the assessment of patients with abnormal liver blood tests or high risk for liver disease. This novel pathway will allow assessment of patients in Community Liver Assessment Clinics (CLAC) with the expectation that only 20% of patients assessed would need to be seen in secondary care for further assessment. The investigators expect, to be assessing, 750 patients per year in this pathway. This pathway will bring together a large group of patients with liver disease. As part of the clinical assessment the investigators will be undertaking investigations to diagnose disease and assess extent. This will generate significant information, that the investigators currently use in isolation to make the aforementioned assessments. In this study, the investigators would like to bring together all this data into a curated database. To this end, the investigators would offer all patients who attend the CLAC for clinical need to enrol into the study. This would generate a database to combine all data, alongside some other, non-invasive tests, done alongside routine clinical tests. This project will address this lack of answers by teaming up with innovative companies to make software that joins together a wide range of different tests to make an algorithm to detect disease earlier.

Non-Alcoholic Fatty Liver DiseaseNon-alcoholic SteatohepatitisAlcoholic Liver DiseaseLiver Fibroses

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

have a negative

What the study is looking for

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

Who cannot take part

  • ✗Age \< 18 years.
  • ✗Pregnancy/breast-feeding. Women of childbearing potential (not \>2 years post- menopausal and/or not surgically...
  • ✗Isolated bilirubinaemia.
  • ✗Known pre-existing liver disease.
  • ✗Acutely unwell.
See the full criteria
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.

Where Is This Study? (1 UK site)

Manchester University NHS Foundation Trust

Manchester M13 9WL, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Varinder Athwal

Sponsor contact

CONTACT

0161 291 5354 Varinder.athwal@manchester.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2026-02