NCT02037867 Nottingham Community Liver Biomarkers Cohort
| NCT ID | NCT02037867 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Nottingham |
| Condition | Chronic Liver Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2013-05 |
| Primary Completion | 2033-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,000 participants in total. It began in 2013-05 with a primary completion date of 2033-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Neil Guha, MRCP, PhD
PRINCIPAL INVESTIGATOR
University of Nottingham
Frequently Asked Questions
Who can join the NCT02037867 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Liver Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02037867 currently recruiting?
Yes, NCT02037867 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Nottingham to inquire about joining.
Where is the NCT02037867 trial being conducted?
This trial is being conducted at Nottingham, United Kingdom.
Who is sponsoring the NCT02037867 clinical trial?
NCT02037867 is sponsored by University of Nottingham. The principal investigator is Neil Guha, MRCP, PhD at University of Nottingham. The trial plans to enroll 2,000 participants.