Community Liver Biomarkers Cohort
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.
Chronic Liver Disease
Hazardous Alcohol Use
Type 2 Diabetes
Persistently Elevated ALT
Device: Fibrosis Biomarkers
|Study Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration:||20 Years|
|Official Title:||The Stratification of Liver Disease in the Community Using Fibrosis Biomarkers|
- Liver and cardiovascular-related mortality [ Time Frame: 20 years ] [ Designated as safety issue: No ]Death recorded as resulting from cardiovascular or liver-related causes
- Liver Cirrhosis [ Time Frame: 20 years ] [ Designated as safety issue: No ]Incidence of compensated and decompensated cirrhosis diagnosis during the study period.
- Cardiovascular Disease [ Time Frame: 20 years ] [ Designated as safety issue: No ]Incidence of cardiovascular disease events(defined as symptomatic coronary or cerebrovascular disease)during the study period.
- All-cause mortality [ Time Frame: 20 years ] [ Designated as safety issue: No ]Recording of any death during the study period
Biospecimen Retention: Samples Without DNA
Serum and urine samples stored a -80 degrees Celsius.
|Study Start Date:||May 2013|
|Estimated Study Completion Date:||May 2033|
|Estimated Primary Completion Date:||May 2033 (Final data collection date for primary outcome measure)|
Patients identified with one of the below chronic liver disease risk factors and undergoing community liver disease stratification using fibrosis biomarkers:
Device: Fibrosis Biomarkers
Sequential liver disease stratification with serum biomarker and liver stiffness scan (Transient Elastography)
Other Name: AST:ALT ratio, BARD score, Transient Elastography, Fibroscan
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT02037867
|Nottingham Digestive Diseases Biomedical Research Unit||Recruiting|
|Nottingham, Notts, United Kingdom, NG7 2UH|
|Contact: Neil Guha, MRCP, PhD 01159249924 ext 70609 email@example.com|
|Contact: David J Harman, BMedSci, BMBS 01159249924 ext 70610 firstname.lastname@example.org|
|Principal Investigator: Neil Guha, MRCP, PhD|
|Sub-Investigator: David J Harman, BMedSci, BMBS|
|Sub-Investigator: Guruprasad P Aithal, FRCP, PhD|
|Sub-Investigator: Stephen D Ryder, MRCP, PhD|
|Sub-Investigator: Martin W James, MRCP, PhD|
|Sub-Investigator: Emilie A Wilkes, MRCP, PhD|
|Principal Investigator:||Neil Guha, MRCP, PhD||University of Nottingham|