Biomarker Breast Pap Test
This will be a Phase I study. During the Phase I study, our goals are: 1) screen a number of cancer biomarkers in Nipple Aspirate Fluid (NAF) from women who have no mammographically detectable tumors, and those who have detectable tumors, 2) identify all the detectable markers and 3) establish that biomarkers detected in NAF could also be detected in the biopsied tumor tissue that was removed for diagnostic purpose in subjects who have detectable tumors.
|Study Design:||Observational Model: Cohort|
|Study Start Date:||March 2013|
|Estimated Study Completion Date:||November 2014|
|Estimated Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
Subjects who have no mammographically detectable tumors
This group will be evaluated for marker presence in NAF. no drugs administered
Subjects who have non-cancerous growths
This group will be evaluated to study whether marker(s) detected in NAF are also expressed in non-cancerous tumors. No drugs administered
subjects who have cancerous growths
In this group, any markers detected in NAF could also be detected in tumor tissues. No drugs administered.