Identifying Patterns in the Breath of Individuals With Breast Cancer

Description

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.

Conditions

Breast Cancer

Study Overview

Study Details

Study overview

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.

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

Identifying Patterns in the Breath of Individuals With Breast Cancer

Condition
Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Washington

GW Comprehensive Breast Center, Washington, District of Columbia, United States, 20037

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

40 Years to 74 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Breathe BioMedical Inc,

Study Record Dates

2026-12