Development of an Integrated Multi-channel Artificial Nose for Cancer Detection (UNos)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Area Under the Receiver Operating Characteristic Curve (AUC) for Cancer Classification
研究概览
简要总结
This interventional diagnostic study evaluated a multi-channel artificial nose (UNos) medical device for analysis of exhaled breath in participants with head and neck squamous cell carcinoma and healthy volunteers. Participants underwent a standardized breath sampling procedure, and exhaled air was analyzed using semi-selective sensor arrays to generate quantitative breath pattern signatures. The study evaluated the ability of the device to discriminate cancer participants from healthy controls based on sensor-derived breath profiles.
详细描述
This prospective, non-randomized, interventional diagnostic study evaluated the performance of a multi-channel artificial nose (UNos) medical device for exhaled breath analysis in participants with head and neck squamous cell carcinoma and in healthy volunteers.
Participants were assigned to one of two parallel groups:
Adults with histologically confirmed squamous cell carcinoma of the head and neck.
Healthy adult volunteers without known malignant disease.
All participants underwent a standardized breath collection procedure according to the study protocol. Exhaled breath samples were collected into gas sampling bags under controlled conditions and subsequently analyzed using a multi-channel electronic nose system equipped with semi-selective chemical sensors designed to detect volatile organic compound-related signal patterns.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers.
- •Non-smokers and smokers
- •Aged over 18 years.
- •The person must be able to understand and sign the consent form for participation in the clinical trial ("informed consent").
排除标准
- •Throat or pharyngeal cancer that is not squamous cell carcinoma
- •Known malignant disease elsewhere in the body.
- •Previously treated malignant disease anywhere in the body, with the exception of non-melanoma skin cancer or cervical CIS
- •Diabetes.
- •Age under 18 years.
研究组 & 干预措施
Head and Neck Cancer Participants - Breath Analysis
Participants with histologically confirmed head and neck squamous cell carcinoma underwent a standardized exhaled breath sampling procedure according to study protocol. Breath samples were collected into gas sampling bags under controlled conditions and analyzed using a multi-channel artificial nose (UNos) medical device equipped with semi-selective chemical sensors. The device generated quantitative sensor response values representing volatile organic compound patterns in exhaled air. No therapeutic intervention was performed, and the procedure did not influence clinical management.
干预措施: Artificial or Electronic Nose (E-Nose) medical device (Device)
Healthy Volunteers - Breath Analysis
Healthy adult volunteers underwent the same standardized exhaled breath sampling procedure as cancer participants. Breath samples were collected into gas sampling bags and analyzed using the multi-channel artificial nose (UNos) system to obtain quantitative sensor response patterns. The procedure was non-invasive and performed for diagnostic signal acquisition only, without any therapeutic intervention.
干预措施: Artificial or Electronic Nose (E-Nose) medical device (Device)
结局指标
主要结局
Area Under the Receiver Operating Characteristic Curve (AUC) for Cancer Classification
时间窗: At baseline visit
Area under the receiver operating characteristic (ROC) curve calculated from the artificial nose device classification model distinguishing participants with head and neck squamous cell carcinoma from healthy volunteers.
次要结局
- Sensitivity of Artificial Nose Device for Cancer Detection(At baseline visit)
- Specificity of Artificial Nose Device for Cancer Detection(At baseline visit)