Spots Global Cancer Trial Database for Breath Test to Predict Breast Cancer and Outcome of Mammography

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Trial Identification

Brief Title: Breath Test to Predict Breast Cancer and Outcome of Mammography

Official Title: Breath Test to Predict Breast Cancer and Outcome of Mammography

Study ID: NCT04755829

Conditions

Breast Cancer

Abnormal Mammogram, Unspecified

Interventions

BreathX test for breath VOCs

Study Description

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

Detailed Description: 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.