NCT04755829

Breath Test to Predict Breast Cancer and Outcome of Mammography

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Menssana Research, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Breast Cancer
• Abnormal Mammogram, Unspecified

Interventions

Type	Name	Description
DEVICE	BreathX test for breath VOCs	Breath samples are collected into an ultra-clean bag and breath VOCs are analyzed with GC-SAW.

Timeline

• Start date: 2021-03-01
• Primary completion: 2023-03-01
• Completion: 2023-03-01
• First posted: 2021-02-16
• Last updated: 2021-02-16

Locations

3 sites across 3 countries: Germany, Netherlands, United Kingdom