Integrated Diagnostics for Early Diagnosis of Liver Disease (ID LIVER)

February 5, 2026 updated by: Manchester University NHS Foundation Trust
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients attending Community Liver Assessment Clinic within Manchester with deranged liver function tests, fatty liver on ultrasound or a history of alcohol excess

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in patient numbers requiring secondary care appointments for the investigation of advanced liver fibrosis.
Time Frame: At study completion; within 3 years
Our project aims to identify patients with liver fibrosis in the community and only those with evidence of advanced fibrosis or cirrhosis being triaged on into secondary care hepatology services.
At study completion; within 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To define the metrics involved in the diagnosis of advanced liver fibrosis or cirrhosis
Time Frame: At study completion; Within 3 years
Through combining the data from basic clinical bloods such as LFTs, non-invasive scoring systems such as FIB-4 and NAFLD fibrosis scores along with the novel biomarkers, we will use this data through AI to develop algorithms that will aid the diagnosis of advanced fibrosis/cirrhosis.
At study completion; Within 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Manchester University NHS Foundation Trust

Collaborators

University of Nottingham
University of Manchester
Innovate UK

Investigators

  • Principal Investigator: Varinder Athwal, Manchester University NHS Foundation Trust/Manchester University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 21, 2020

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

October 21, 2020

First Submitted That Met QC Criteria

December 7, 2020

First Posted (Actual)

December 14, 2020

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B00907

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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