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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 Silbiotech.
Recruitment status was:  Not yet recruiting
Information provided by (Responsible Party):
Indira Poola, Ph.D, Silbiotech Identifier:
First received: September 7, 2012
Last updated: September 10, 2012
Last verified: September 2012
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 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.


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: Indira Poola, Ph.D, Principal Investigator, Silbiotech Identifier: NCT01683305     History of Changes
Other Study ID Numbers: Silbiotech:2012-01
Study First Received: September 7, 2012
Last Updated: September 10, 2012

Keywords provided by Silbiotech:
Subjects processed this record on May 23, 2017