Biomarker Breast Pap Test

NCT ID: NCT01683305

Last Updated: 2012-09-11

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2014-11-30

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

Study Design

• Observational Model Type: COHORT

Study Groups

Subjects who have no mammographically detectable tumors

This group will be evaluated for marker presence in NAF. no drugs administered

No interventions assigned to this group

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

No interventions assigned to this group

subjects who have cancerous growths

In this group, any markers detected in NAF could also be detected in tumor tissues. No drugs administered.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Any female subject aged 18 years or older

Exclusion Criteria

• none

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Silbiotech

INDUSTRY

Sponsor Role: lead

Responsible Party

Indira Poola, Ph.D

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Silbiotech:2012-01

Identifier Type: -

Identifier Source: org_study_id