Identifying Patterns in the Breath of Individuals With Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: 40 years — 74 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Using Infrared Spectroscopy to Analyze Volatile Organic Compounds in the Breath of Patients to Detect Breast Cancer
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 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.
Primary outcome measures
- Primary Outcome 1 [Time frame: 24 months]
Secondary outcome measures (5)
- Secondary Outcome 1 [Time frame: 24 months]
- Secondary Outcome 2 [Time frame: 24 months]
- Secondary Outcome 3 [Time frame: 24 months]
- Secondary Outcome 4 [Time frame: 24 months]
- Secondary Outcome 5 [Time frame: 24 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
United States · 4 centers
- GW Comprehensive Breast Center — Washington D.C.
- Mayo Clinic Breast Clinic — Jacksonville
- Duke University Medical Cente — Durham
- Weinstein Imaging Associates — Pittsburgh
Identifiers
NCT: NCT06512350 · BBMCP2024