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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
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
University of Erlangen, Erlangen, , Germany
Zuyderland Medical Center, Heerlen, , Netherlands
Frimley Health NHS Foundation Trust, Middlesex, , United Kingdom
Name: Alexandra Tenovici
Affiliation: Frimley Health NHS Foundation Trust
Role: PRINCIPAL_INVESTIGATOR
Name: Marc Lobbes, MD
Affiliation: Zuyderland Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: Peter Fasching, MD
Affiliation: University of Erlangen-Nürnberg
Role: PRINCIPAL_INVESTIGATOR