Detection of Colorectal Cancer From Exhaled Air. Part II: Validation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 511
- 试验地点
- 2
- 主要终点
- sensitivity/specificity for CRC
研究概览
简要总结
Colorectal cancer (CRC) is the third most common new cancer diagnosis and a major cause of morbidity and mortality throughout the world. Early detection and treatment are critical factors in the course and prognosis of CRC, and screening programs have proven to be an important means to reduce both CRC related mortality and secondary economic burden.
The diagnostic accuracy of non-invasive screening tests is still limited and a follow-up colonoscopy is required for confirmation of the diagnosis. The faecal occult blood test (FIT) is the most commonly used fecal screening test worldwide, but sensitivity for CRC ranges between 53%-99% depending on the cut-off values used, whereas sensitivity for advanced adenomas is disturbingly low (39%-57%).
The aim of this study is to evaluate the diagnostic accuracy of the AeonoseTM to distuinguish people with CRC from healthy controls.
详细描述
Rationale: An electronic nose (eNose) is an artificial olfactory system that analyses volate organic compounds (VOCs) in exhaled breath. Exhaled human breath is mainly composed of inorganic compounds, inert gases and VOCs. VOCs are exhaled in very low concentrations and reflect pathological processes such as inflammation, oxidation, infection and neoplasms. The perspective is that metabolic and biochemical processes in several pathological situations cause different endogenous VOCs to arise, were they can serve as non-invasive biomarkers for certain diseases.
Primary objective: To evaluate the diagnostic accuracy of the AeonoseTM to distinguish the breathing pattern from patients with colorectal cancer from healthy controls using the previously established breathing pattern.
Secondary objecitves:
- To evaluate the diagnostic accuracy of the AeonoseTM to distinguish the breathing pattern from patients with polyps (e.g. advanced adenomas, sessile serrated lesions).
- To determine the influence of colonic cleansing (laxative use) on breathing patterns.
Study population: Adult patients referred for colonoscopy.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •Suspicion for (pre-)malignant lesions of the colon scheduled for colonoscopy
排除标准
- •Subjects with other known malignancies
- •Subjects with established inflammatory bowel disease
结局指标
主要结局
sensitivity/specificity for CRC
时间窗: 38 weeks
Diagnostic accuracy of the Aeonose to detect CRC in terms of sensitivity and specificity
次要结局
- sensitivity/specificity for advanced adenomas and/or sessile serrated lesions.(38 weeks)
- Sensitivity/specificity for detection of CRC and/or polyps before and after bowel preparation(38 weeks)