Actively Recruiting
Integrated Diagnostics for Early Diagnosis of Liver Disease
Led by Manchester University NHS Foundation Trust · Updated on 2026-02-09
1200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Manchester University NHS Foundation Trust
Lead Sponsor
U
University of Manchester
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are exploring a new approach to improve early diagnosis of liver fibrosis by combining patient data with novel blood biomarkers, genetic analysis, and stool microbiome testing. This observational study aims to create an algorithm that detects liver disease earlier than current methods, addressing a major health challenge where many cases are found only at advanced, less treatable stages. The study involves patients at risk or with abnormal liver blood tests attending Community Liver Assessment Clinics. Participants in this study will undergo routine clinical assessments along with extra diagnostic tests including blood tests for specific genetic markers (single nucleotide polymorphisms), blood samples for novel biomarker analysis, and faecal microbiome analysis using stool samples. These tests help gather comprehensive data to develop a new diagnostic pathway, expecting that only about 20% of patients will need secondary care follow-up. The study plans to assess approximately 750 patients per year and compile all collected data into a curated database. During the study, participants will provide blood and stool samples alongside their clinical assessments. Data from these tests and patient evaluations will be combined and analyzed to better define metrics for diagnosing advanced liver fibrosis or cirrhosis. The main outcome measured is a reduction in patients needing secondary care appointments for advanced liver fibrosis investigation, evaluated within three years. The study also involves follow-up assessments and safety monitoring throughout participation.
CONDITIONS
Brief Title
Integrated Diagnostics for Early Diagnosis of Liver Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- All patients referred to Community Liver Assessment Clinic.
- Male or female over 18 years of age.
- Females must not be pregnant or breastfeeding.
You will not qualify if you...
- Under 18 years of age.
- Pregnant or breastfeeding women.
- Women of childbearing potential must have a negative pregnancy test.
- Isolated bilirubinaemia.
- Known pre-existing liver disease.
- Acutely unwell patients.
- Suspected malignancy or cancer diagnosis prior to enrollment in study care pathway for liver disease assessment only, no other liver disease pathway or clinical trial participation allowed during this time period for liver disease pathway patients to ensure clear interpretation of the data collected in this study protocol and for the study database to be utilised for a future study for liver disease diagnostics and treatment pathways for the NHS and UK population in partnership with various Innovator companies and the University of Manchester and Manchester University NHS Foundation Trust only for the purposes of this study and no other purpose or research study or clinical trial participation is permitted during the study period for this cohort of patients for the liver disease pathway only.
- Suspected malignancy or cancer diagnosis prior to enrollment in study care pathway for liver disease assessment only, no other liver disease pathway or clinical trial participation allowed during this time period for liver disease pathway patients to ensure clear interpretation of the data collected in this study protocol and for the study database to be utilised for a future study for liver disease diagnostics and treatment pathways for the NHS and UK population in partnership with various Innovator companies and the University of Manchester and Manchester University NHS Foundation Trust only for the purposes of this study and no other purpose or research study or clinical trial participation is permitted during the study period for this cohort of patients for the liver disease pathway only.
- Suspected malignancy or cancer diagnosis prior to enrollment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single timepoint during clinical assessment
Participants undergo diagnostic tests including blood tests for genetic markers, stool sample collection for microbiome analysis, and blood sampling for novel biomarker analysis alongside routine clinical assessments.
1 visit (in-person) with stool sample collection
Duration - Up to 3 years
Participants who undergo routine liver care are observed and their diagnostic data is collected to inform early disease detection and management.
Ongoing follow-up visits as part of routine care
Trial Site Locations
Total: 1 location
1
Manchester University NHS Foundation Trust
Manchester, Greater Manchester, United Kingdom, M13 9WL
Actively Recruiting
Research Team
V
Varinder Athwal
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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