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NCT06512350 · ClinicalTrials.gov registry record
Identifying Patterns in the Breath of Individuals With Breast Cancer
A clinical trial of Breast Cancer, sponsored by Breathe BioMedical.
- Recruiting
- Registry status
- 1,000
- Enrollment target
- 3
- Study locations
NCT06512350: Recruiting study of Breast Cancer, sponsored by Breathe BioMedical.
NCT06512350 is a study of Breast Cancer that is actively recruiting participants, run by Breathe BioMedical. The registered enrollment target is 1,000 participants, below the 2,802-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (64% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06512350, a study of Breast Cancer, is actively recruiting participants, sponsored by Breathe BioMedical.
- RECRUITING
- Registry status
- 1,000 participants
- Enrollment target
- 3
- Study locations
Study 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.
Conditions Studied
Study Locations (3)
District of Columbia
- GW Comprehensive Breast Center - Washington D.C.
Florida
- Mayo Clinic Breast Clinic - Jacksonville
North Carolina
- Duke University Medical Cente - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2025-02-25 |
| Est. Completion | 2026-12 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06512350
The ClinicalTrials.gov registry entry for NCT06512350 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 1,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,802-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (64% lower). The listed sponsor is Breathe BioMedical, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 0 interventions.
NCT06512350 reports 3 study locations spanning 3 distinct geographic areas - top geographies include District of Columbia, Florida, North Carolina.
Frequently Asked Questions
What is clinical trial NCT06512350 about?
NCT06512350 is a clinical study titled "Identifying Patterns in the Breath of Individuals With Breast Cancer". 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 can...
What is the current status of trial NCT06512350?
This trial is currently recruiting. The enrollment target is 1,000 participants. The study started on 2025-02-25. Estimated completion is 2026-12.
What conditions does trial NCT06512350 study?
This clinical trial studies the following conditions: Breast Cancer.
Who is sponsoring clinical trial NCT06512350?
This trial is sponsored by Breathe BioMedical, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06512350 being conducted?
This trial has 3 study locations across District of Columbia, Florida, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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