Integrated Diagnostics for Early Diagnosis of Liver Disease

NCT04666402 | Recruiting

• 1 other identifier: B00907
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-Alcoholic Fatty Liver Disease; Non-alcoholic Steatohepatitis; Alcoholic Liver Disease; Liver Fibroses

Outcome Measures

Primary Outcomes (1)

• Reduction in patient numbers requiring secondary care appointments for the investigation of advanced liver fibrosis.

  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 Outcomes (1)

• To define the metrics involved in the diagnosis of advanced liver fibrosis or cirrhosis

  At study completion; Within 3 years

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead
• University of Manchester: collaborator
• University of Nottingham: collaborator
• Innovate UK: collaborator

Study Sites (1)

Manchester University NHS Foundation Trust

Manchester, Greater Manchester, M13 9WL, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Serum for specific single nucleotide polymorphisms will be collected

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Liver Diseases, Alcoholic; Liver Cirrhosis

Interventions

Hematologic Tests; Polymorphism, Single Nucleotide

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Polymorphism, Genetic; Genetic Variation; Genetic Phenomena

Study Officials

• Varinder Athwal

  Manchester University NHS Foundation Trust/Manchester University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Varinder Athwal

CONTACT

0161 291 5354; Varinder.athwal@manchester.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: December 14, 2020
• Study Start: October 21, 2020
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)