The Utility of Breath Biopsy as a Screening Tool for HCC: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Volatile organic compounds specific to HCC
研究概览
简要总结
The aim of this pilot study is to examine whether there is a discriminating ability of the breath sample analysis to capture biomarkers specific to the HCC in the breath of affected individuals. If positive, our research could open up a new horizon for cost-effective and feasible screening tools.
详细描述
20 Participants will be included in the study. Ten Cirrhotic patients with HCC and 10 Cirrhotic patients without HCC.
The first group is patients with HCC secondary to cirrhosis. The second group will be patients with cirrhosis who are currently on the standard surveillance program with no HCC. Confirmation of the absence of HCC would have been ensured via a recent advanced imaging modality (dynamic CT scan or MRI) in the ongoing surveillance programme.
Participants will breathe into either a mouthpiece or collection tube then Breath samples will be analyzed via an analyzer to detect the volatile organic compounds (VOC) and quantitatively compare them
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cirrhotic patients with HC.
- •Cirrhotic patients without HCC
排除标准
- •Patients with more than one primary cancer (HCC in addition to other cancer)
- •Patients who are not aware of the diagnosis
- •Patients in whom the diagnosis of HCC is not clear and only suspected
- •Patients with severe chronic obstructive pulmonary disease (COPD) or severe asthma.
结局指标
主要结局
Volatile organic compounds specific to HCC
时间窗: 6 months
Quantitative analysis of the volume and pattern of volatile compounds in the breath of the individuals with HCC compared to that in the breath of individuals without HCC but with the same underlying disease
次要结局
未报告次要终点