Clinical Performance Evaluation of CanScan Breath Analyzer for Breast Cancer Screening.
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
- 主要终点
- Sensitivity and specificity:
研究概览
简要总结
This is a clinical performance evaluation of the CanScan breath analyzer for breast cancer screening study. This study aims to evaluate the CanScan Breath Analyzer’s effectiveness in screening breast cancer. It involves 200 females, divided into two groups of 100 each: the Cancer Group (newly diagnosed breast cancer patients) and the Control Group (females with negative breast cancer screening results). The primary objectives are to assess the screening accuracy and performance of the CanScan Breath Analyzer, including sensitivity, specificity, and accuracy, which would be compared with standard breast screening methods. In contrast, secondary objectives focus on cost-effectiveness, acceptability, and operational feasibility. The study is prospective, non-randomized, and observational, involving a single visit for breath sample collection after 3 hours of fasting. Participants’ demographics, medical history, and relevant information are gathered, and the breath samples are analyzed using the CanScan device. The results are compared with traditional screening methods. The study also includes criteria for subject inclusion and exclusion, emphasizing the importance of obtaining informed consent and ensuring participants meet specific conditions. The study’s outcomes will provide insights into the tool’s screening accuracy, subject acceptance, and operational feasibility, contributing to the potential integration of the CanScan Breath Analyzer into routine clinical practice for breast cancer screening.
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
- •Willing to sign the informed consent form.
- •Females aged 18 years and above.
- •Confirmed cases of breast cancer -positive mammography/breast sonography/breast examination report (but not exposed to any treatment cycle/surgery for tumor removal); and willing to undergo further MRI /biopsy if required.
- •Women with negative mammography/breast sonography reports and willing to undergo further MRI if required.
排除标准
- •Patients undergoing breast cancer treatment.
- •Patients who have undergone surgery for breast tumor removal.
- •Patients with negative mammography/breast sonography reports.
- •Patients without breast examination report from PI.
- •Pregnant & lactating mothers.
- •Previous history of treated breast cancer, or cancer of any other site, except basal cell carcinoma of the skin.
- •Consumption of alcohol, pan, gutkha within less than 12 hrs.
- •Smoking within the last one month 9)Breast cancer patients who do not share a biopsy report.
结局指标
主要结局
Sensitivity and specificity:
时间窗: 32
The study will estimate sensitivity and specificity rates for the CanScan Breath Analyzer in screening all stage breast cancer. This would measure the tool’s effectiveness in correctly distinguishing between breast cancer patients and healthy subject.
时间窗: 32
次要结局
- Breath Test acceptance & subject satisfaction: Highlight the non-invasive nature of the screening method, measuring subject’s ease of use compared to traditional screening methods like mammograms.(4 weeks)
研究者
Dr Nagesh Sirsath
Renatus Cancer Center