Detection of Amplification of Her2 Fluorescent in Situ Hybridization (FISH) in Breast Tissue Sections

NCT ID: NCT01066507

Last Updated: 2010-02-10

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

COMPLETED

Total Enrollment

126 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-07-31

Study Completion Date

2010-01-31

Brief Summary

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The purpose of the study is the identification of amplification level in human breast tissue. The imaging system is intended for diagnostic use as an aid to the pathologist in the detection, counting and classification of Her2 FISH stained tissue samples.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Breast cancer

Slides containing breast cancer paraffin embedded tissue sections.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Well stained breast tissue slides with bright Her2 signals

Exclusion Criteria

* Very old slides that were already bleached
Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Applied Spectral Imaging Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Applied Spectral Imaging Ltd.

Principal Investigators

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Sheila Dobin, Ph.D.

Role: STUDY_DIRECTOR

Section Chief, Cytogenetics

Locations

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PLUS Diagnostics

Lakewood, New Jersey, United States

Site Status

Scott & White Hospital, Texas

Temple, Texas, United States

Site Status

Sheba Medical Center, Pathology Dep.

Tel Aviv, , Israel

Site Status

Countries

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United States Israel

Other Identifiers

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ASI-Her2F

Identifier Type: -

Identifier Source: org_study_id

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