Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04755829
Status:
UNKNOWN
Last Update Posted:
2021-02-16
First Post:
2021-02-08
Brief Title:
Breath Test to Predict Breast Cancer and Outcome of Mammography
Sponsor:
Menssana Research Inc
Organization:
Menssana Research Inc
Study Overview
Official Title:
Breath Test to Predict Breast Cancer and Outcome of Mammography
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None