Using Infrared Spectroscopy to Analyze Volatile Organic Compounds in the Breath of Patients to Detect Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,175
- 试验地点
- 8
- 主要终点
- Compare the breath spectra from patients with breast cancer and from healthy controls using mathematical/statistical models to further develop Breathe BioMedical's technology and machine learning algorithms.
研究概览
简要总结
Researchers will compare the breath profiles of women with breast cancer and those without to determine whether there are disease-specific patterns that can be leveraged to facilitate breast cancer detection.
Women with mammogram-confirmed breast tissue density undergoing standard-of-care breast cancer screening will be invited to participate. Those who provide informed consent will provide one breath sample and fill out a questionnaire about their medical history with help from the research coordinators. Breath samples will be collected prior to standard of care biopsy or MRI, and patients will be stratified into the case or control group based on their test results.
The primary goal of this project is to use exhaled alveolar breath and the subsequent spectral data produced by Breathe BioMedical's cavity ring-down spectrometer to further develop Breathe BioMedical's technology and machine learning algorithms to determine the feasibility of detecting breast cancer in women aged 40 to 74.
Secondarily, this project aims to identify patterns of VOCs that are either over- or under-represented in participants with breast cancer when compared to the breath profiles of participants without breast cancer. This project will also assess performance characteristics of the technology (e.g. sensitivity, specificity, false negative rate, and false positive rate) including subgroup analyses. This project aims to understand intra-subject variability by exploring differences in breath signatures before and after definitive management of breast cancer, including surgical resection.
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
- 40 Years 至 74 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female (sex as assigned at birth);
- •Aged 40 - 74 years;
- •Mammography confirmed breast tissue density (BI-RADS density score of A, B, C or D);
- •Scheduled for standard of care biopsy or MRI;
- •Fluent in language of consent (English, Spanish, or French);
- •Ability to give informed consent;
- •Able to provide a breath sample.
排除标准
- •Prior history of breast cancer;
- •Previous surgical biopsy or surgical excision of breast cancer in the past six months;
- •History of cancer (except basal cell or squamous cell carcinoma of the skin) in the past year;
- •Acute respiratory infection and/or symptoms in the past seven days;
- •MRI BI-RADS 3 undergoing active surveillance (MRI requiring six-month follow-up).
- •Pregnant or become pregnant during the study.
研究组 & 干预措施
Breast Cancer Cohort
Subjects with biopsy-proven primary breast cancer.
Control Cohort
Subjects with a negative MRI (for surveillance or diagnostic purposes with BI-RADS 1 or 2) that confirms the absence of breast cancer.
Breast Cancer Cohort - Surgery
Subjects with biopsy-proven primary breast cancer, who have undergone surgery at Mayo Clinic Florida or Duke University will be screened to provide a second breath sample. The second breath sample will be collected at least six months following the completion of all standard of care treatment (excluding adjuvant endocrine therapy and adjuvant HER2 directed monoclonal antibody such as trastuzumab).
结局指标
主要结局
Compare the breath spectra from patients with breast cancer and from healthy controls using mathematical/statistical models to further develop Breathe BioMedical's technology and machine learning algorithms.
时间窗: 12 months
Using exhaled alveolar breath and the subsequent spectral data produced by Breathe BioMedical's infrared cavity ring-down spectrometer, the goal is to identify patterns of VOCs that are either over- or under-represented in the breath profiles of subjects with breast cancer compared to the breath profiles of healthy controls. Machine learning performance characteristics will also be assessed (e.g., sensitivity, specificity, false negative rate, and false positive rate) including subgroup analyses. This will allow for the determination of the feasibility of detecting breast cancer in women with dense breast tissue.
Primary Outcome 1
时间窗: 24 months
Classification performance metrics characteristics (e.g. sensitivity, specificity, false negative rate, and false positive rate) derived from spectral features of exhaled alveolar breath obtained using Breathe BioMedical's cavity ring-down spectrometer in women aged 40-74.
次要结局
- Secondary Outcome 1(24 months)
- Secondary Outcome 2(24 months)
- Secondary Outcome 3(24 months)
- Secondary Outcome 4(24 months)
- Secondary Outcome 5(24 months)