Status:
RECRUITING
Identifying Patterns in the Breath of Individuals With Breast Cancer
Lead Sponsor:
Breathe BioMedical Inc
Collaborating Sponsors:
Mayo Clinic
George Washington University
Conditions:
Breast Cancer
Eligibility:
FEMALE
40-74 years
Brief 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 de...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 25 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT06512350
Start Date
February 25 2025
End Date
December 1 2026
Last Update
August 20 2025
Active Locations (3)
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1
GW Comprehensive Breast Center
Washington D.C., District of Columbia, United States, 20037
2
Mayo Clinic Breast Clinic
Jacksonville, Florida, United States, 32224
3
Duke University Medical Cente
Durham, North Carolina, United States, 27710