Observational Study Aimed to Characterize a System for Breast and Colon Cancer Diagnosis by Breath Testing - NaNose Study
试验速览
- 阶段
- 不适用
- 入组人数
- 560
- 试验地点
- 2
- 主要终点
- System performance
研究概览
简要总结
The concept of breath testing for various diseases has been around since ancient greece. It has been hypothesized that cancer is generating a unique pattern of compounds in patients' breath. This study is trying to characterize a novel system, based on nanoparticles technology, for cancer diagnosis through breath samples.
详细描述
Cancer is accompanied by increased oxidative stress and induction of polymorphic cytochrome P- 450 mixed oxidase enzymes (CYP). Both processes affect the abundance of volatile organic compounds (VOCs) in the breath because oxidative stress causes lipid peroxidation of polyunsaturated fatty acids in membranes, producing alkanes and methylalkanes which are catabolized by CYP.
In the Technion labs, a new system for breath samples diagnosis, is being developed. The system is based on Nanoparticles technology.
The current study will try to identify colon and breast cancer patients through their breath samples and discriminate them from healthy individuals.
Men and women coming for colonoscopy or breast biopsy will be recruited for the study. Breath samples will be taken from all volunteers before the medical test. Subjects with positive cancer results by biopsy will be the test groups for both diseases, all others will be the control.
The research goal is to test the NaNose system ability to discriminate between healthy and sick.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women attending Rambam medical center for either breast biopsy or colonoscopy.
- •Suspicious finding on breast imaging requiring a biopsy.
- •Complaints indicating the possibility of colon cancer: Blood in stool, weight loss, constipation, anemia, family history of colon cancer.
排除标准
- •Other known active malignancy.
- •History of malignant disease and treatments.
结局指标
主要结局
System performance
时间窗: 10 months
Sensitivity and specificity of NaNose system in diagnosing cancer
次要结局
未报告次要终点