CTRI/2025/04/084786尚未招募不适用
An open-label, comparative crossover study of CanScan medical device for volatile marker analysis in exhaled breath of breast cancer patients and healthy women under fasting and non-fasting conditions.
Kozhnosys Private Limited1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2025年9月1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
- 110
- 试验地点
- 1
- 主要终点
- CanScan accuracy (sensitivity, specificity) for breast cancer patients vs. healthy subjects.
研究概览
简要总结
This is a comparative crossover study of the CanScan device for volatile marker analysis in exhaled breath of breast cancer patients (Mammography Positive) and healthy women (Mammography negative). VOCs detected with specific sensors and the sensitivity and specificity of the CanScan would be assessed. The study will be able to differentiate between VOC of cancer and non-cancer patients. The study will be conducted on 60 mammogram-positive women and 50 mammogram-negative women fulfilling the inclusion and exclusion criteria.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 30.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- Female
入选标准
- •Willing to fill out the informed consent form.
- •Female in the age group 30 to 80 years with or without common medical conditions like Hypertension, Hyperlipidaemia, Hypothyroidism, Arthritis, Asthma, GERD, Diabetes, PCOD, Vitamin D deficiency, Calcium Deficiency, Iron deficiency, Menopause etc.
- •Confirmed cases of breast cancer (positive mammography) but not exposed to any previous treatment cycle or surgery.
- •If CanScans result is positive, but negative mammography reports the patient should agree to do an MRI to verify a false positive or false negative result.
- •Willing to undertake a routine mammography test.
- •Women with positive mammograms should share the biopsy report after breast cancer confirmation or non-confirmation.
排除标准
- •Age group below 30 years.
- •Already undergoing cancer treatment.
- •Undergone surgery for breast tumor removal.
- •The patient is not ready for an MRI after a negative mammography report and a positive CanScan result.
- •The patient is not sharing the biopsy report.
- •Excluding pregnant participants.
结局指标
主要结局
CanScan accuracy (sensitivity, specificity) for breast cancer patients vs. healthy subjects.
时间窗: 16 Weeks
次要结局
- VOC (Volatile organic compounds) profile in(cancer: Detection of biomarkers using Canscan.)
研究者
Dr Gaurav Jaiswal
TGH Onco-life Cancer Center
研究点 (1)
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