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Biomarker Breast Pap Test

This study is not yet open for participant recruitment.
Verified September 2012 by Silbiotech
Sponsor:
Information provided by (Responsible Party):
Indira Poola, Ph.D, Silbiotech
ClinicalTrials.gov Identifier:
NCT01683305
First received: September 7, 2012
Last updated: September 10, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition
Tumors

Study Type: Observational
Study Design: Observational Model: Cohort

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Any woman age 18 or older

Criteria

Inclusion Criteria:

  • Any female subject aged 18 years or older

Exclusion Criteria:

  • none
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Indira Poola, Ph.D, Principal Investigator, Silbiotech
ClinicalTrials.gov Identifier: NCT01683305     History of Changes
Other Study ID Numbers: Silbiotech:2012-01
Study First Received: September 7, 2012
Last Updated: September 10, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Silbiotech:
biomarker,
NAF
Subjects

ClinicalTrials.gov processed this record on May 16, 2013