Clinical Investigation Plan to evaluate the false positive detection rate of the CanScan Breath Analyzer in patients newly diagnosed with cancers other than breast cancer.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 82
- 试验地点
- 1
研究概览
简要总结
This single center observational study will evaluate the false positive detection rate of the CanScan Breath Analyzer in adult patients newly diagnosed with cancers other than breast cancer. The CanScan device, previously validated for breast cancer detection, uses volatile organic compound profiling to identify cancer-related metabolic signatures in exhaled breath. The study will assess diagnostic specificity by comparing CanScan results with confirmed clinical diagnoses obtained through standard procedures such as biopsy, imaging, cytology, and histopathology. Approximately 82 participants will be enrolled to represent diverse cancer types and demographic backgrounds. Findings will inform refinement of the CanScan algorithm and improve its accuracy for breast cancer detection by reducing misclassification risk.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults aged 18 years and above.
- •Male and female participants.
- •Adults with a newly diagnosed and confirmed cancer.
- •Able to provide informed consent.
- •Willing and able to undergo breath sample collection.
排除标准
- •History of breast cancer (past or present).
- •Presence of severe respiratory illness or conditions affecting breath sample quality (e.g., COPD, active tuberculosis).
- •Already undergoing cancer treatment.
- •Undergone surgery for cancer tumor removal.
- •Undergoing chemo/radiation therapy for cancer treatment.
- •Pregnant & lactating mothers.
- •Inability to comply with study procedures.
研究者
Dr Gaurav Jaswal
TGH Onco-life Cancer Center, General Hospital Campus