Breast Cancer, Reasoning, and Activity Intervention
NCT04816006
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8
Phoenix, Arizona, United States
View Trial DetailsNCT Number: NCT06512350
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.
Interested in participating?
Request Info40 year–74 year
Female
Observational
GW Comprehensive Breast Center, Washington D.C., District of Columbia, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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.
Time frame: 24 months
Discriminative features between women with breast cancer and women without breast cancer.
Time frame: 24 months
Features associated with breast cancer between participants with dense breast tissue and those with non-dense breast tissue.
Time frame: 24 months
Classification performance characteristics (e.g. sensitivity, specificity, false negative rate, and false positive rate) including subgroup analyses.
Time frame: 24 months
Variability in features before and after definitive management of breast cancer, including surgical resection.
Time frame: 24 months
Pooled and analyzed de-identified data from this, previous, and future breath analysis studies to continue to develop Breathe BioMedical's technology and machine learning algorithms.
Contact information is provided by the study sponsor or research team.
Breathe BioMedical Inc
Industry
Using Infrared Spectroscopy to Analyze Volatile Organic Compounds in the Breath of Patients to Detect Breast Cancer
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