Biomarker Breast Pap Test

NCT01683305 | Unknown

• 1 other identifier: Silbiotech:2012-01
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tumors

Keywords

biomarker,; NAF; Subjects

Study Arms (3)

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 Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any woman age 18 or older

You may qualify if:

• Any female subject aged 18 years or older

You may not qualify if:

• none

Sponsors & Collaborators

• Silbiotech: lead

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 7, 2012
• First Posted: September 11, 2012
• Study Start: March 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: September 11, 2012

Record last verified: 2012-09