Detection of Amplification of Her2 Fluorescent in Situ Hybridization (FISH) in Breast Tissue Sections (Her2F test)

February 9, 2010 updated by: Applied Spectral Imaging Ltd.

Concordance Study for Amplification Detection of Her2 FISH in Breast Tissue Sections

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

126

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel Aviv, Israel
        • Sheba Medical Center, Pathology Dep.
  • United States
    • New Jersey
      • Lakewood, New Jersey, United States, 08701
        • PLUS Diagnostics
    • Texas
      • Temple, Texas, United States, 76508
        • Scott & White Hospital, Texas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

The breast samples were taken from female patients after cut biopsies. Paraffin embedded blocks were prepared and the secssion slides were stained with the PathVysion prove for Her2 FISH applification detection

Description

Inclusion Criteria:

  • Well stained breast tissue slides with bright Her2 signals

Exclusion Criteria:

  • Very old slides that were already bleached

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Breast cancer
Slides containing breast cancer paraffin embedded tissue sections.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Applied Spectral Imaging Ltd.

Investigators

  • Study Director: Sheila Dobin, Ph.D., Section Chief, Cytogenetics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

February 9, 2010

First Submitted That Met QC Criteria

February 9, 2010

First Posted (Estimate)

February 10, 2010

Study Record Updates

Last Update Posted (Estimate)

February 10, 2010

Last Update Submitted That Met QC Criteria

February 9, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASI-Her2F

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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