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Checking liver scarring in the community with blood and scan tests

Tests blood and liver scan methods to find early liver scarring in at-risk adults.

Key facts

Who runs it
University of Nottingham
Where
Nottingham, United KingdomSee the site
Trial code
Registry title
Nottingham Community Liver Biomarkers Cohort
Status
Recruiting
People taking part
2,000 people, planned
Started
May 2013
Expected to end
May 2033
Type of study
Observational
Treatments tested
  • Fibrosis Biomarkers
Record updated
8 February 2019

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with a risk factor for liver disease: hazardous alcohol use, type 2 diabetes, obesity, or a persistently raised ALT blood result.

Age
18 years or over
Sex
Men and women can join
Disease stage
No liver disease stage is asked for. People need a risk factor: hazardous alcohol use (more than 14 units a week for women, more than 21 for men), type 2 diabetes, obesity, or persistently elevated ALT with normal liver serology.
Biomarker or test result
Persistently elevated ALT with normal liver serology is one way to join.

Main reasons for not taking part

  • Active cancer when joining the study
  • Cannot give informed consent
  • Known liver disease proven by tissue examination before joining the pilot pathway

The registry criteria, word for word

Show all 4 criteriaShow less

Who can take part

  • Adult patients aged 18 years or over (male or female) with primary risk factor for liver disease:; Hazardous alcohol use (>14 units/week for women, >21 units/week for men); Type 2 Diabetes; Obesity; Persistently elevated ALT with normal liver serology

Who cannot take part

  • Known presence of histologically proven liver disease prior to pilot pathway participation
  • Active malignancy at study enrolment
  • Inability to provide informed consent for study enrolment

Where in United Kingdom

  • NIHR Nottingham Digestive Diseases Biomedical Research UnitNottingham, United KingdomContact: Neil Guha, MRCP, PhDTaking people

About the trial

What the trial wants to find out

Deaths due to advanced liver scarring (liver cirrhosis) continue to increase, and liver disease is now the 3rd leading cause of premature death in the United Kingdom. The majority of liver disease is lifestyle related (alcohol, obesity and associated type 2 diabetes, injecting drug use) and therefore reversible if caught at a precirrhosis stage. However, current liver function blood tests are poor inadequate, and subsequently a large burden of liver disease is currently missed.

Read full original descriptionShow less

A variety of noninvasive liver biomarkers (blood and imaging tests) have been developed which identify liver disease accurately at earlier stages of scarring. The identification of liver disease in the community, where previous studies have discovered a large burden of previously unidentified but significant liver disease, is therefore a feasible place to develop new liver disease investigation pathways using these noninvasive markers.

In collaboration with the Department of Health, Nottingham University Hospitals have commenced a pilot community liver disease pathway in two General Practices in Nottingham in February 2012. Patients with liver risk factors (hazardous alcohol use, obesity or type 2 diabetes)are invited to take part in the pathway. Patients undergo a simple blood test (AST:ALT ratio and BARD score), with a high test result requiring referral for a liver stiffness scan (Fibroscan)which is performed in the community setting. High threshold scan values are reviewed by a consultant liver specialist in a community liver clinic. Preliminary findings show that the pathway accurately identifies patients with early liver scarring and previously unidentified significant liver disease. The participating General Practitioners have also noted a striking number of patients finally engaging in important lifestyle changes following pathway implementation. A second phase of the pilot pathway, in 2 Inner City General Practices with a total practice population of c.14,000 patients commenced in June 2013.

We have subsequently designed this cohort study, where pilot participants will be consented for follow up over a long period. We will assess future liver-related and cardiovascular events (including death), and perform qualitative patient interviews to assess the reasons for and persistence of lifestyle changes after liver disease investigation. We hypothesize that stratification of liver disease in the community will unearth a significant amount of previously undetected but significant chronic liver disease. Moreover, we will evaluate whether stratification of liver disease using these tests predicts future liver and cardiovascular disease and death, and whether stratification has an impact on patient's future lifestyle choices.

The group in the trial

  • Patients

    Patients identified with one of the below chronic liver disease risk factors and undergoing community liver disease stratification using fibrosis biomarkers: * Hazardous alcohol use (\>14 units per week in females, \>21 units per week in males, alcohol AUDIT score \>=8 or read code relevant to alcohol abuse on GP system) * Type 2 Diabetes * Obesity * Persistently raised serum ALT level, negative liver serology, and absence of above 2 risk factors

    Treatment: Fibrosis Biomarkers

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
The Stratification of Liver Disease in the Community Using Fibrosis Biomarkers
Plain-language title
Checking liver scarring in the community with blood and scan testsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Publications
Record updated
8 February 2019