Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Normal screening mammogram (BIRADS 1 or 2)

Abnormal screening mammogram (BIRADS 3 to 6)

Breath samples are collected into an ultra-clean bag and breath VOCs are analyzed with GC-SAW.

BreathX test for breath VOCs

Michael Phillips, MD

Jonah Phillips, MBA

Peter Fasching, MD

Hanna Huebner

Marc Lobbes, MD

Alexandra Tenovici, MD

Alexandra Tenovici

To validate a breath test that predicts risk of breast cancer and an abnormal mammogram.

We will determine the accuracy of volatile organic compounds (VOCs) in the breath as predictors of risk of breast cancer and an abnormal mammogram. Breath samples will be collected using an ultra-clean collection bag and analyzed with gas chromatography surface acoustic wave detection (GC SAW)

The study will be performed in two phases:

Phase 1: Model-building phase (cross-sectional study): Breath VOCs will be employed to construct multivariate algorithms that distinguish between normal women and those with breast cancer and abnormal screening mammograms.

Phase 2: Model-testing phase (cross-sectional study): The predictive accuracy of these algorithms will be tested to predict outcomes in normal women and those with breast cancer and abnormal screening mammograms.

Breath Test to Predict Breast Cancer and Outcome of Mammography

Determination of the sensitivity, specificity, and positive and negative predictive values of a breath test for biomarkers that predict the risk of an abnormal mammogram.

Determination of the sensitivity, specificity, and positive and negative predictive values of a breath test for biomarkers that predict the risk of an biopsy-proven breast cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Breath Test to Predict Breast Cancer and Outcome of Mammography	NCT04755829	Breast Cancer Abnormal Mammog...	BreathX test fo...	18 Years -	Menssana Research, Inc.
Breath Test to Predict Breast Cancer and Outcome of Mammography	NCT04755829	Breast Cancer Abnormal Mammog...	BreathX test fo...	18 Years -	Menssana Research, Inc.

Spots Global Cancer Trial Database for abnormal mammogram, unspecified