Clinical trial

Nottingham Community Liver Biomarkers Cohort

Recruiting now · Not applicable · 1 countries · Registry ID NCT02037867

Recruiting nowNot applicableObservational

What this study is about

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. 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionChronic Liver Disease, Alcohol Use Disorder, Type 2 Diabetes, Persistently Elevated ALT, Obesity

Full registry criteria

Inclusion Criteria: * 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 Exclusion Criteria: * Active malignancy at study enrolment * Inability to provide informed consent for study enrolment * Known presence of histologically proven liver disease prior to pilot pathway participation

Treatments and study arms

Fibrosis Biomarkers

Device

Liver disease stratification with liver stiffness scan (Transient Elastography) Analysis of diagnostic performance of serum fibrosis markers (as listed above) Whole blood samples obtained for DNA analysis

Primary outcomes

Liver and cardiovascular-related mortality20 years

Death recorded as resulting from cardiovascular or liver-related causes

Study locations

1 locations were listed when this page was built. The first 40 are shown.

NIHR Nottingham Digestive Diseases Biomedical Research Unit🇬🇧 Nottingham, Notts, United Kingdom
Neil Guha, MRCP, PhDContact
Rebecca Harris, BMedSci, BMBSContact
Neil Guha, MRCP, PhDPrincipal Investigator