Detection of Colorectal Cancer in Patients With a Positive Fecal Immunochemical Test Using an Electronic Nose Device (AeoNoseTM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,345
- 试验地点
- 2
- 主要终点
- The ability of AeonoseTM to distinguish between patients with and without colorectal cancer in a FIT-positive population in terms of sensitivity and specificity.
研究概览
简要总结
The present study aims to investigate the diagnostic accuracy of exhaled breath analysis with the Aeonose (the eNose Company, Zutphen, the Netherlands) to distinguish the breath of patients suspected for CRC (based on a positive fecal immunochemical test), who are truly diagnosed with CRC, from patients suspected for CRC in whom this diagnosis is rejected after colonoscopy.
详细描述
Study rationale:
Colonoscopy plays a key role in all colorectal cancer (CRC) screening modalities. An important limitation of colonoscopy remains that the diagnostic accuracy and therapeutic safety of colonoscopy both depend on several physician and patient-related factors. Significant amounts of polyps are missed during colonoscopy and severe untoward effects still occur in 0.1%-0.3% of all colonoscopy procedures, even among expert examiners. Moreover, the burdensome nature of the procedure and the necessity of full bowel preparation negatively influences participation rates and the use of colonoscopy as a CRC screening test is limited by healthcare costs and the expertise needed to perform the screening. These disadvantages of colonoscopy warrant the development of a new, non-invasive, accurate CRC screening test.
An electronic nose device is an artificial olfactory system that analyses volate organic compounds (VOCs) in exhaled breath. The use of electronic noses has already been assessed as a potential non-invasive diagnostic biomarker test for lung cancer, breast cancer and malignant melanomas. The present study aims to investigate the diagnostic accuracy of exhaled breath analysis with the AeonoseTM (The eNose Company, Zutphen, the Netherlands) to distinguish the breath of patients suspected for CRC (based on a positive fecal immunochemical test (FIT)), who are truly diagnosed with CRC, from patients suspected for CRC in whom this diagnosis is rejected after colonoscopy.
Objectives:
- To investigate the diagnostic accuracy of exhaled breath analysis with the AeonoseTM to distinguish the breath of patients suspected for CRC based on a positive FIT test, who are truly diagnosed with CRC, from patients suspected for CRC in whom this diagnosis is rejected after colonoscopy.
- To investigate the diagnostic accuracy of exhaled breath analysis with the AeonoseTM for other (pre-)malignant colon lesions (e.g. advanced adenomas, non-advanced adenomas, and sessile serrated lesions).
- To assess the acceptance rate of using the AeonoseTM device.
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
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients between the ages of 55 and 75 years referred for a colonoscopy procedures after a positive FIT test.
排除标准
- •Patients with a history of any type of malignancy (not including basal-cell skin cancer (BCC) and squamous-cell skin cancer (SCC))
- •Prior surgical resection of any portion of the colon
- •Patients who are unable to perform breathing maneuver needed for Aeonose-analysis of exhaled air
结局指标
主要结局
The ability of AeonoseTM to distinguish between patients with and without colorectal cancer in a FIT-positive population in terms of sensitivity and specificity.
时间窗: 1.5 year
Sensitivity and specificity of the Aeonose
次要结局
- The diagnostic accuracy of AeonoseTM for other (pre-)malignant colon lesions (e.g. advanced adenomas, non-advanced adenomas, and sessile serrated lesions).(1.5 year)
- Acceptance rate of AeonoseTM.(1.5 year)