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Biomarker Breast Pap Test

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2012 by Indira Poola, Ph.D, Silbiotech.
Recruitment status was:  Not yet recruiting
ClinicalTrials.gov Identifier:
First Posted: September 11, 2012
Last Update Posted: September 11, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Indira Poola, Ph.D, Silbiotech
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 Type: Observational
Study Design: Observational Model: Cohort

Further study details as provided by Indira Poola, Ph.D, Silbiotech:

Estimated Enrollment: 500
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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Any woman age 18 or older

Inclusion Criteria:

  • Any female subject aged 18 years or older

Exclusion Criteria:

  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Indira Poola, Ph.D, Principal Investigator, Silbiotech
ClinicalTrials.gov Identifier: NCT01683305     History of Changes
Other Study ID Numbers: Silbiotech:2012-01
First Submitted: September 7, 2012
First Posted: September 11, 2012
Last Update Posted: September 11, 2012
Last Verified: September 2012

Keywords provided by Indira Poola, Ph.D, Silbiotech: