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

This study has been completed.
Sponsor:
Information provided by:
Applied Spectral Imaging Ltd.
ClinicalTrials.gov Identifier:
NCT01066507
First received: February 9, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
  Purpose

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.


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Concordance Study for Amplification Detection of Her2 FISH in Breast Tissue Sections

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Applied Spectral Imaging Ltd.:

Biospecimen Retention:   Samples Without DNA

Paraffin embedded tissue sections


Enrollment: 126
Study Start Date: July 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Breast cancer
Slides containing breast cancer paraffin embedded tissue sections.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Criteria

Inclusion Criteria:

  • Well stained breast tissue slides with bright Her2 signals

Exclusion Criteria:

  • Very old slides that were already bleached
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01066507

Locations
United States, New Jersey
PLUS Diagnostics
Lakewood, New Jersey, United States, 08701
United States, Texas
Scott & White Hospital, Texas
Temple, Texas, United States, 76508
Israel
Sheba Medical Center, Pathology Dep.
Tel Aviv, Israel
Sponsors and Collaborators
Applied Spectral Imaging Ltd.
Investigators
Study Director: Sheila Dobin, Ph.D. Section Chief, Cytogenetics
  More Information

No publications provided

Responsible Party: Tsafrir Kolatt, Applied Spectral Imaging Ltd.
ClinicalTrials.gov Identifier: NCT01066507     History of Changes
Other Study ID Numbers: ASI-Her2F
Study First Received: February 9, 2010
Last Updated: February 9, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Applied Spectral Imaging Ltd.:
Her2
FISH
Breast cancer
Amplification

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on October 17, 2012