NCT05400408尚未招募不适用
Detection of Colorectal and Pancreatic Cancers Using Breath Analysis - Feasibility Study.
Scentech Medical Technologies Ltd1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2024年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- identification of Volatile Organic Compounds that can be related to Colorectal malignancy.
研究概览
简要总结
Detection of Colorectal and Pancreatic Cancers Using Breath Analysis - Feasibility Study
详细描述
A diagnostic prospective study with no anticipated risks or constraints. Main Objective: To quantify differences in exhaled breath VOCs of patients with colorectal or pancreatic cancers compared with cohorts without cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 to 85 years at the time of consent.
- •Scheduled for colonoscopy or Endoscopic Retrograde Cholangio Pancreatography.
- •Fasted >6 hours, consuming water only.
- •Able to provide informed written consent.
排除标准
- •Lacks capacity or is unable to provide informed written consent.
- •Pregnant or lactating woman.
- •Histologically confirmed cancer in any organ.
结局指标
主要结局
identification of Volatile Organic Compounds that can be related to Colorectal malignancy.
时间窗: Through the study completion, up to 1 year.
Comparison of identity and concentration of Volatile Organic Compounds profile found among colorectal patients and the identity and concentration of Volatile Organic Compounds profile found among Healthy controls.
次要结局
- Test Sensitivity and specificity for colorectal polyps.(Through the study completion, up to 1 year.)
- Test Sensitivity and specificity for pancreatic cancer.(Through the study completion, up to 1 year.)
研究者
研究点 (1)
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