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临床试验/NCT02037867
NCT02037867招募中不适用

The Stratification of Liver Disease in the Community Using Fibrosis Biomarkers

University of Nottingham1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2013年5月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
2,000
试验地点
1
主要终点
Liver and cardiovascular-related mortality

研究概览

简要总结

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.

详细描述

Objectives:

  1. To establish a community based cohort with risk factors for liver disease and stratification for liver disease severity using non-invasive biomarkers.
  2. To establish the incidence of liver and cardiovascular morbidity and mortality in a community cohort.
  3. To explore the quantitative and qualitative indicators to potential alterations in patient lifestyle following stratification of liver disease to inform future intervention development.
  4. To evaluate novel blood markers of liver fibrosis and cirrhosis on a large cohort of primary care patients

Study Configuration:

Longitudinal Cohort Study with long-term follow up

Setting:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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
  • Persistently elevated ALT with normal liver serology

排除标准

  • 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

结局指标

主要结局

Liver and cardiovascular-related mortality

时间窗: 20 years

Death recorded as resulting from cardiovascular or liver-related causes

次要结局

  • Liver Cirrhosis(20 years)
  • Cardiovascular Disease(20 years)
  • All-cause mortality(20 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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