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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01066507
Recruitment Status : Completed
First Posted : February 10, 2010
Last Update Posted : February 10, 2010
Information provided by:
Applied Spectral Imaging Ltd.

Brief Summary:
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 or disease
Breast Cancer

Study Type : Observational
Actual Enrollment : 126 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Concordance Study for Amplification Detection of Her2 FISH in Breast Tissue Sections
Study Start Date : July 2008
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

Breast cancer
Slides containing breast cancer paraffin embedded tissue sections.

Biospecimen Retention:   Samples Without DNA
Paraffin embedded tissue sections

Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Tsafrir Kolatt, Applied Spectral Imaging Ltd. Identifier: NCT01066507     History of Changes
Other Study ID Numbers: ASI-Her2F
First Posted: February 10, 2010    Key Record Dates
Last Update Posted: February 10, 2010
Last Verified: February 2010

Keywords provided by Applied Spectral Imaging Ltd.:
Breast cancer