Identifying Patterns in the Breath of Individuals With Breast Cancer

Breathe BioMedical Inc1,000 enrolled

Overview

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 dense breast tissues 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 with dense breast tissue. 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.

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Breast Cancer

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 74 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Female (sex as assigned at birth); * Aged 40 - 74 years; * Mammography confirmed dense breast tissue (BI-RADS density score of 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. Exclusion Criteria: * Mammography confirmed fatty breast tissue (BI-RADS A or B); * 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.

Outcomes

Primary Outcomes

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.

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.

Time frame: 12 months