Breath Volatile Organic Compounds (VOC) Analysis Using Proton Transfer Reaction Mass Spectrometry (PTR-MS)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- VOC Signature Collection.
研究概览
简要总结
The purpose of this clinical trial is to evaluate whether volatile organic compound (VOC) signatures detected in the breath of patients with cancer can serve as a potential screening tool for the early detection of cancer.
详细描述
This study aims to determine whether metabolic changes associated with cancer produce distinct alterations in exhaled breath compared with those of healthy individuals. Breath samples will be analyzed using machine learning techniques to identify volatile organic compound (VOC) patterns and develop diagnostic algorithms capable of detecting multiple types of cancer. The long-term goal is to establish a noninvasive, breath-based screening tool that can facilitate the early detection of various cancers.
Additionally, patients and healthy participants who consent to this study may opt in to be contacted in the future to provide additional breath samples.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age ≥ 18 at the time of consent. Male and female patients to be tested.
- •Capable of understanding written and/or spoken English language.
- •Able to provide informed consent.
- •Cancer of any type.
- •Newly diagnosed cancer and untreated or established diagnosis of cancer. For established cancer patients, no active anti-cancer treatment for more than one month (reasons for no treatment are such as relapse, progression of cancer, refractory, or intolerance to treatment etc.)
排除标准
- •Under the age of
- •Anticipated inability to complete breath sampling procedure.
- •Unable to provide informed consent.
- •Pregnant women
- •Active respiratory infection symptoms
- •Recent use of antibiotics
- •Difficulty in performing coached exhalation
- •Individuals who are unable to follow the instructions
- •Cancer patients who are on active treatment for cancer or have received cancer treatment within one month
结局指标
主要结局
VOC Signature Collection.
时间窗: 2 Years
The successful collection of breath samples from 1000 cancer patients and 1000 healthy volunteers.
Assess the sensitivity of Machine Learning (ML) Algorithm In The Test Dataset.
时间窗: 1 Years
Using the training dataset, qualitative output generated by the PTR-MS instrument will be analyzed using machine learning methods to identify volatile organic compound (VOC) patterns associated with different cancer types, including pancreatic, esophageal, hepatocellular carcinoma, lung, and ovarian cancers. The trained machine learning model will be tested using the dataset.
次要结局
- Assess The Specificity and Accuracy of ML Analysis In The Test Dataset.(1 year)