Evaluation of multi-cancer screening through breath samples performed by biomedical detection dogs in India
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,000
- 试验地点
- 6
- 主要终点
- 1Cancer type Performance Evaluation The performance of BreathEasy will be critically evaluated to determine its ability to detect multiple types of newly diagnosed cancer through breath samples with the aim of ascertaining its accuracy and reliability in the screening process
研究概览
简要总结
This study aims to validate the effectiveness of the BreathEasy test, a breath-based multi-cancer screening test, in India. It addresses key challenges in cancer screening by focusing on affordability, accessibility, and accuracy. The study will involve around 3000 participants across Hubli and Bangalore sites, with breath samples collected and analyzed for volatile organic compounds (VOCs), which are indicative of cancer.
BreathEasy integrates volatolomics - the study of volatile organic compounds (VOCs) emitted from biological samples, with canine olfaction and advanced technologies such as wearable EEG brain-computer interfaces (BCIs) and machine learning. Trained biomedical detection dogs, equipped with these devices, detect specific cancer-related VOCs, while machine learning models analyze their neural responses to identify cancer biomarkers. This innovative system capitalizes on the unique "odor print" of diseases, offering a novel, non-invasive approach to cancer detection.
The study’s double-blind design ensures objectivity, as neither handlers nor experimenters know which samples are cancer-positive. Key objectives include evaluating the sensitivity and specificity of canine detection, particularly in early-stage cancers, and exploring the influence of lifestyle factors like smoking on detection accuracy. The study is expected to provide a cost-effective and scalable cancer screening tool, laying the foundation for broader integration of canine-assisted diagnostics into India’s healthcare system, especially in regions with limited access to advanced medical facilities.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 40.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Case inclusion criteria: Confirmed cancer diagnosis via tissue biopsy and/or pathologist report.
- •Willingness to consent to study participation Control inclusion criteria: Able to provide consent.
- •1 No known medical condition or 2 Diagnosed with chronic obstructive pulmonary disease or other pulmonary conditions or Chronic kidney disease or other nephrology conditions or 3 Underwent biopsy with suspected cancer with non malignant report.
排除标准
- •Case exclusion criteria: Patients who have already initiated cancer treatments Control exclusion criteria for all groups: 1 previous cancer diagnosis at any point 2 Diagnosis of communicable diseases like TB that can be transmitted via breath or sputum 3 Pregnant women or those who gave birth in last three months.
结局指标
主要结局
1Cancer type Performance Evaluation The performance of BreathEasy will be critically evaluated to determine its ability to detect multiple types of newly diagnosed cancer through breath samples with the aim of ascertaining its accuracy and reliability in the screening process
时间窗: 12 weeks
2Stage wise Performance Analysis The performance of BreathEasy will be analyzed to determine its effectiveness in detecting early versus late stage cancers
时间窗: 12 weeks
次要结局
- Effect of Lifestyle Variables(The influence of lifestyle factors, such as smoking & chewing tobacco, on the performance of BreathEasy will be investigated to understand potential limitations & identify areas for adjustment in the screening process)
研究者
Akash Kulgod
Vigilomics Bioscience Private Limited