ClinicalTrials.gov
ClinicalTrials.gov Menu

Biomarker Breast Pap Test

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.
ClinicalTrials.gov Identifier: NCT01683305
Recruitment Status : Unknown
Verified September 2012 by Indira Poola, Ph.D, Silbiotech.
Recruitment status was:  Not yet recruiting
First Posted : September 11, 2012
Last Update Posted : September 11, 2012
Sponsor:
Information provided by (Responsible Party):
Indira Poola, Ph.D, Silbiotech

Brief Summary:
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 or disease
Tumors

Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Study Start Date : March 2013
Estimated Primary Completion Date : November 2014
Estimated Study Completion Date : November 2014

Group/Cohort
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

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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:


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

Keywords provided by Indira Poola, Ph.D, Silbiotech:
biomarker,
NAF
Subjects