CTRI/2025/12/099452尚未招募不适用
Clinical performance evaluation of the CanScan breath analyzer for breast cancer screening.
Jilma Peruvanagt1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2026年2月27日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
研究概览
简要总结
This diagnostic accuracy study will evaluate the clinical performance of the CanScan Breath Analyzer for breast cancer screening. CanScan is a novel non-invasive device that detects volatile organic compounds in exhaled breath associated with breast cancer metabolism. The study will compare CanScan results with standard diagnostic methods including mammography, sono mammography, and biopsy to assess sensitivity, specificity, positive predictive value, and negative predictive value. Approximately 200 women will be enrolled, including 100 with newly diagnosed breast cancer and 100 controls with negative mammography findings.
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
- Female
入选标准
- •Women undergoing mammography/Sono-Mammography in the diagnostic lab collaborator of Kozhnosys.
- •Women with confirmed breast cancer by biopsy report/FNAC/Histopathology.
排除标准
- •Patients undergoing breast cancer treatment.
- •Pregnant & lactating mothers.
- •Previous history of treated breast cancer or cancer of any other site.
- •History of alcohol or any type of tobacco consumption.
- •A person with breathing difficulties or respiratory illness cannot provide an adequate breath sample.
- •Breast cancer patients who do not share a biopsy report.
研究者
Dr Gaurav Jaswal
TGH Onco-life Cancer Center, General Hospital Campus
研究点 (1)
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