Identifying Patterns in the Breath of Individuals With Breast Cancer

StatusRecruiting
PhaseNot specified
Started

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Trial flagged as At Risk
Primary completion moved at least 32 days later Dec 2027 → Feb 2028
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Record History

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  1. Minor Primary and study completion pushed from Dec 2027 to Feb 2028 Show 4 more changesShow less
    • Study sites: 4 to 5
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 5 of 5 entries
    • Collaborators: 4 to 5
  2. Notable Enrollment target: 1000 to 5175v5 Show 6 more changesShow less
    • Primary and study completion dates pushed to Dec 2027
    • Primary endpoint revised
    • Study sites: 3 to 4
    • Eligibility criteria shortened, about 7 words
    • Secondary endpoints expanded, about 15 words
    • Collaborators: 3 to 4
  3. Minor Study sites: 1 to 3v4
  4. Re-verified, no change to tracked fieldsv3
  5. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 7 more changesShow less
    • Start date changed from estimate of Aug 2024 to Feb 25, 2025
    • Study sites: 0 to 1
    • Primary completion date: Aug 2025 to Feb 2026
    • Study completion date: Dec 2025 to Dec 2026
    • Eligibility criteria expanded, about 7 words
    • Collaborators: 2 to 3
    • Study arms: 2 to 3
  6. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06512350
Lead Sponsor Breathe BioMedical Inc
Collaborators: Mayo Clinic, George Washington University, Duke University, Weinstein Imaging Associates, Réseau de Santé Vitalité Health Network
Conditions
(from sponsor)
Breast Cancer
Related terms Breast Neoplasms
Enrollment 5,175 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov