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NCT06512350 | RECRUITING | Breast Cancer

Identifying Patterns in the Breath of Individuals With Breast Cancer
Sponsor:

Breathe BioMedical Inc

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 detection. Women with mammogram-confirmed dense breast tissues 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 with dense breast tissue. 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.

Condition or disease

Breast Cancer

Study Type : OBSERVATIONAL
Estimated Enrollment : 1000 participants
Official Title : Using Infrared Spectroscopy to Analyze Volatile Organic Compounds in the Breath of Patients With Breast Cancer
Actual Study Start Date : 2025-02-25
Estimated Primary Completion Date : 2026-02
Estimated Study Completion Date : 2026-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 40 Years to 74 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: 1
Criteria
Inclusion Criteria
  • * 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 Criteria
  • * 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.
Identifying Patterns in the Breath of Individuals With Breast Cancer

Location Details

NCT06512350

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, District of Columbia

GW Comprehensive Breast Center

Washington, District of Columbia, United States, 20037