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Biomarker Breast Pap Test

NCT ID: NCT01683305

Last Updated: 2012-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Tumors

Keywords

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biomarker, NAF Subjects

Study Design

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Observational Model Type

COHORT

Study Groups

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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

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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

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Silbiotech

INDUSTRY

Sponsor Role lead

Responsible Party

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Indira Poola, Ph.D

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Silbiotech:2012-01

Identifier Type: -

Identifier Source: org_study_id