RECRUITING

Identifying Patterns in the Breath of Individuals With Breast Cancer

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood 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.

Official Title

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

Quick Facts

Study Start:2025-02-25
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06512350

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.

Ages Eligible for Study:40 Years to 74 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Female (sex as assigned at birth);
  2. * Aged 40 - 74 years;
  3. * Mammography confirmed dense breast tissue (BI-RADS density score of C or D);
  4. * Scheduled for standard of care biopsy or MRI;
  5. * Fluent in language of consent (English, Spanish, or French);
  6. * Ability to give informed consent;
  7. * Able to provide a breath sample.
  1. * Mammography confirmed fatty breast tissue (BI-RADS A or B);
  2. * Prior history of breast cancer;
  3. * Previous surgical biopsy or surgical excision of breast cancer in the past six months;
  4. * History of cancer (except basal cell or squamous cell carcinoma of the skin) in the past year;
  5. * Acute respiratory infection and/or symptoms in the past seven days;
  6. * MRI BI-RADS 3 undergoing active surveillance (MRI requiring six-month follow-up).
  7. * Pregnant or become pregnant during the study.

Contacts and Locations

Study Contact

Sandra Veenstra
CONTACT
(506) 855-2400
sandra.veenstra@breathebiomedical.com

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Breathe BioMedical Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-25
Study Completion Date2026-12

Study Record Updates

Study Start Date2025-02-25
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • Breast Cancer
  • Dense Breast Tissue
  • Infrared Spectroscopy
  • Machine Learning

Additional Relevant MeSH Terms

  • Breast Cancer