Biomarker Breast Pap Test

Silbiotech

Status: Unknown

Conditions: Tumors

Study type: Observational

Funder types: Industry

Identifiers

NCT01683305

Silbiotech:2012-01

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Any female subject aged 18 years or older

Exclusion criteria

• none

Trial design

500 participants in 3 patient groups

Subjects who have no mammographically detectable tumors

Description:

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

Subjects who have non-cancerous growths

Description:

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

Description:

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