Clinical trial Recruiting at 1 site Observational Ages 18 and up

Improving early diagnosis of liver disease using integrated diagnostics

Official title: Integrated Diagnostics for Early Diagnosis of Liver Disease

Run by Manchester University NHS Foundation Trust · NCT04666402 · Data updated 2026-11-12

This study is trying to improve how quickly and accurately liver disease is diagnosed by combining different tests and information from around 750 patients who are at risk or have abnormal liver blood tests.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment1200 (estimated)
SponsorManchester University NHS Foundation Trust
Government
Locations1 site (Manchester, Greater Manchester)
StatusRecruiting
StartedOctober 21, 2020
Main results expectedMarch 31, 2027
Study endsMarch 31, 2027
Registry record updatedFebruary 9, 2026
Trial IDNCT04666402 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are adults over 18 years old who have been referred to a Community Liver Assessment Clinic.

Probably not a fit

Patients under 18 years old, those with known pre-existing liver disease, or those who are acutely unwell may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to enhance the early diagnosis of liver disease by integrating data from patients with liver conditions, novel blood biomarkers, single nucleotide polymorphism (SNP) analysis, and fecal microbiome analysis. The study will assess patients referred to Community Liver Assessment Clinics (CLAC) to create a comprehensive database that combines various diagnostic tools. By implementing this new assessment pathway, the investigators expect to reduce the number of patients needing secondary care while improving the identification of liver fibrosis. The study will involve approximately 750 patients annually, focusing on those with abnormal liver blood tests or at high risk for liver disease.

Why it matters

Potential benefit: If successful, this approach could lead to earlier and more accurate diagnosis of liver disease, allowing for timely intervention and better patient outcomes.

How similar studies have gone: Other studies have shown promise in using integrated diagnostic approaches for liver disease, but this specific methodology is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

  • Manchester University NHS Foundation Trust
    Manchester, Greater Manchester, United Kingdom
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.