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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.
Information provided by:
Applied Spectral Imaging Ltd. Identifier:
First received: February 9, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
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.

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:

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)
Breast cancer
Slides containing breast cancer paraffin embedded tissue sections.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
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

Inclusion Criteria:

  • Well stained breast tissue slides with bright Her2 signals

Exclusion Criteria:

  • Very old slides that were already bleached
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01066507

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

Responsible Party: Tsafrir Kolatt, Applied Spectral Imaging Ltd. 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.:
Breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases processed this record on October 26, 2016