BREATH TEST TO PREDICT BREAST CANCER AND OUTCOME OF MAMMOGRAPHY
Research type
Research Study
Full title
BREATH TEST TO PREDICT BREAST CANCER AND OUTCOME OF MAMMOGRAPHY
IRAS ID
293653
Contact name
Michael Phillips
Contact email
Sponsor organisation
Menssana Research UK Ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Background: Volatile organic compounds (VOCs) in breath provide biomarkers of several different diseases including breast cancer. This study will employ the BreathX system to validate the accuracy of breath biomarkers that predict the risk of an abnormal mammogram and breast cancer, and potentially avert needless procedures. Breath testing with the BreathX system is user-friendly, inexpensive, non-invasive, and intrinsically safe.
Main objectives: We will determine the accuracy of breath VOCs biomarkers as predictors of breast cancer and the outcome of a 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, n= 100: Breath VOCs will be employed to construct multivariate algorithms that distinguish between normal women and those with an abnormal screening mammogram. Phase 2: Model-testing phase (cross-sectional study n=100: The predictive accuracy of these algorithms will be tested in a separate group of women to predict outcomes in normal women and those with breast cancer and abnormal screening mammograms.REC name
East Midlands - Derby Research Ethics Committee
REC reference
21/EM/0290
Date of REC Opinion
14 Jun 2022
REC opinion
Further Information Favourable Opinion