Identifying Patterns in the Breath of Individuals With Breast Cancer

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Breathe BioMedical Inc
Study ID
NCT06512350
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
40 Years - 74 Years
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
Feb 25, 2025
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
5,175 participants (estimated)

Arms

  • Arm: Breast Cancer Cohort
    Subjects with biopsy-proven primary breast cancer.
  • Arm: Control Cohort
    Subjects with a negative MRI (for surveillance or diagnostic purposes with BI-RADS 1 or 2) that confirms the absence of breast cancer.
  • Arm: Breast Cancer Cohort - Surgery
    Subjects with biopsy-proven primary breast cancer, who have undergone surgery at Mayo Clinic Florida or Duke University will be screened to provide a second breath sample. The second breath sample will be collected at least six months following the completion of all standard of care treatment (excluding adjuvant endocrine therapy and adjuvant HER2 directed monoclonal antibody such as trastuzumab).

Primary Outcome Measure

Primary Outcome 1 [ Time Frame: 24 months ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
GW Comprehensive Breast CenterWashington D.C.District of Columbia20037
Geoffrey Rutledge, MD
[email protected]
Geoffrey Rutledge, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic Breast ClinicJacksonvilleFlorida32224
Clinical Trials Referral Office
855-776-0015
James Jakub, MD (PRINCIPAL_INVESTIGATOR)
Duke University Medical CenteDurhamNorth Carolina27710
Jennifer Plichta, MD
[email protected]
919-684-6849
Jennifer Plichta, MD (PRINCIPAL_INVESTIGATOR)
Weinstein Imaging AssociatesPittsburghPennsylvania15220
Danielle E Sharek, MD
412-440-6999
Danielle E Sharek, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Washington D.C., DC

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
GW Comprehensive Breast Center· Washington D.C., DCMayo Clinic Breast Clinic· Jacksonville, FLDuke University Medical Cente· Durham, NCWeinstein Imaging Associates· Pittsburgh, PA

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