RecruitingNCT06512350

Identifying Patterns in the Breath of Individuals With Breast Cancer

Using Infrared Spectroscopy to Analyze Volatile Organic Compounds in the Breath of Patients to Detect Breast Cancer


Sponsor

Breathe BioMedical Inc

Enrollment

5,175 participants

Start Date

Feb 25, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 40 YearsMax Age: 74 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether analyzing exhaled breath can detect patterns linked to breast cancer in women who have dense breast tissue. Breath tests are non-invasive and could one day be used to help identify cancer earlier. **You may be eligible if...** - You are a woman between 40 and 74 years old - Your mammogram showed dense breast tissue (BI-RADS density score C or D) - You are scheduled to have a standard-of-care biopsy or breast MRI - You can communicate fluently in English, Spanish, or French - You are able to provide a breath sample **You may NOT be eligible if...** - Your mammogram showed fatty (non-dense) breast tissue (BI-RADS A or B) - You have a prior history of breast cancer - You have had a surgical biopsy or breast cancer surgery in the past 6 months - You had any other cancer (except some skin cancers) in the past year - You have had a respiratory infection or symptoms in the past 7 days - You are pregnant or become pregnant during the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(4)

GW Comprehensive Breast Center

Washington D.C., District of Columbia, United States

Mayo Clinic Breast Clinic

Jacksonville, Florida, United States

Duke University Medical Cente

Durham, North Carolina, United States

Weinstein Imaging Associates

Pittsburgh, Pennsylvania, United States

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NCT06512350


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