Liver Cancer Disparities in American Indian and Alaska Native Persons
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Compliance with screening protocol
研究概览
简要总结
We are performing a pilot and feasibility randomized controlled trial (RCT) of HCC screening by US + AFP every 6 months (n=100), the current standard-of-care, versus aMRI + AFP every 6 months (n=100) for 12 months (i.e. at time 0, 6 and 12 months) among AI/AN patients with cirrhosis or HBV.
详细描述
We are performing a pilot and feasibility randomized controlled trial (RCT) of HCC screening by US + AFP every 6 months (n=100), the current standard-of-care, versus aMRI + AFP every 6 months (n=100) for 12 months (i.e. at time 0, 6 and 12 months) among AI/AN patients with cirrhosis or HBV.
We will compare the aMRI vs. the US arm with respect to the following outcomes:
- Compliance/feasibility of conducting all three screening tests (0, 6 and 12 months) - Primary Outcome
- Proportion of screening tests conducted that employed the appropriate screening protocol and used appropriate documentation of findings with the LI-RADS system - Primary Outcome
- Proportion diagnosed with HCC and stage at diagnosis - Secondary Outcome
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cirrhosis, any etiology, or chronic HBV infection
- •High risk of HCC
- •Age 18-75
- •Competent to provide informed consent
排除标准
- •Prior diagnosis of HCC
- •Current suspicion of HCC
- •Prior receipt of any organ transplantation
- •Participation in another HCC screening trial
- •CTP score >=10
- •MELD-Na score >20
- •Poor life expectancy (<5 years)
- •Contraindication to MRI
- •Inability to complete study visits
- •Currently pregnant
结局指标
主要结局
Compliance with screening protocol
时间窗: 12 months
Compliance with conducting all three screening tests
Feasibility of screening protocol
时间窗: 12 months
Proportion of screening tests conducted that employed the appropriate screening protocol and used appropriate documentation of findings with the LI-RADS system
次要结局
未报告次要终点
研究者
George Ioannou
Professor, School of Medicine, Gastroenterology
University of Washington