Temporal Variation in Exhaled Volatile Organic Compounds in Response to Therapeutic Intervention in Esophageal Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 4
- 主要终点
- Exhaled breath and urinary VOC concentrations as biomarkers of esophageal cancer
研究概览
简要总结
The purpose of this study is to investigate whether exhaled breath can be used to detect and monitor esophageal cancer.
详细描述
Esophageal cancer ("EG cancer") affects over half a millions people worldwide every year. Early esophageal cancer typically has non-specific symptoms that are often mistaken for benign (non-cancer) conditions. As a result, patients are often referred for further investigations only when they have more prominent symptoms that are typically associated with advanced incurable disease. As a consequence, 7 out of 10 new cases of EG cancer diagnosed are considered to be at an advanced stage, with less than 1 in 3 patients eligible for potentially curative therapy. Better ways of diagnosing esophageal cancer earlier are therefore needed. An ideal test for esophageal cancer would be non-invasive, simple to administer in the community, and cost effective.
The investigators' approach to this clinical challenge is to establish a non-invasive test for the detection of esophageal cancer that is based upon the unique signature of small molecules within exhaled breath. In this study that is being conducted in collaboration with researchers in the United Kingdom (UK), the investigators would like to measure the levels of these small molecules within the breath of patients with esophageal cancer at different times during their treatment: (i) at diagnosis; (ii) after chemoradiotherapy, and; (iii) after surgery. By studying how the small molecules contained within the breath change as a result of esophageal cancer and its treatment, the investigators hope to learn new information that can help develop a new test for this disease.
The investigators will also measure the small molecules within saliva and urine samples collected at the same time as breath in order to study if there are any important differences between these three samples. The investigators will also attempt to measure different bacteria
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-90 years
- •Newly-diagnosed, treatment naïve patients with esophageal and/or gastroesophageal junctional cancer
- •Planning to undergo curative treatment, including neoadjuvant chemoradiotherapy and surgical resection
排除标准
- •Pregnant females
- •Without malignant esophageal disease
- •Malignancy at a secondary site other than the esophagus
- •Undergoing palliative treatment for esophageal cancer
- •Not receiving neoadjuvant chemoradiotherapy and surgical resection for esophageal cancer
- •Inability or unwillingness to provide written informed consent
结局指标
主要结局
Exhaled breath and urinary VOC concentrations as biomarkers of esophageal cancer
时间窗: Before commencing treatment for esophageal cancer
The composition and concentration of volitile organic compounds (VOC) in exhaled breath and urinary samples will be assessed to establish a VOC signature of esophogeal cancer
次要结局
- Patient acceptability of breath test(Before commencing treatment for esophogeal cancer)
- Changes in VOC concentrations that occur in response to therapeutic intervention((i) Before commencing treatment for esophageal cancer, (ii) About 4 - 6 weeks after neoadjuvant therapy, (iii) About 3 - 5 days after surgical resection (but before hospital discharge), (iv) At routine follow up (6 - 12 months after surgery))
- Linkage of longitudinal VOC data to predominant upper gastrointestinal bacterial species((i) Before commencing treatment for esophageal cancer, (ii) About 4 - 6 weeks after neoadjuvant therapy, (iii) About 3 - 5 days after surgical resection (but before hospital discharge), (iv) At routine follow up (6 - 12 months after surgery))