Immunohistochemical (IHC) Scoring for Receptors Expression in Breast Tissues

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: NCT00978276
Recruitment Status : Withdrawn (Personal changes in the company)
First Posted : September 16, 2009
Last Update Posted : January 5, 2016
Information provided by:
Applied Spectral Imaging Ltd.

Brief Summary:

The purpose of this study is the identification and classification of human tissues and cytology specimens and elements therein.

Computer aided technology to assist the pathologists to identify, quantify, characterize and report their findings with regards to one or more diagnoses they should perform. In particular and for example: the scoring of the number of elements and their protein (antibody) expression level within a paraffin embedded tissue section.

Condition or disease
Breast Cancer

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Concordance Study for Over Expression Level of Antibodies Within Breast Tissues
Study Start Date : May 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Biospecimen Retention:   Samples Without DNA
Paraffin embedded tissue sections of the breast

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The breast samples were taken from female patients after tru cut biopsies, lumpectomies or mastectomies. Paraffin embedded blocks were prepared from the specimens out of which sections were stained immunohistochemically with the Vision Bio Systems mouse monoclonal antibodies for Estrogen Receptor (NCL-ER-6F11) and Progesterone Receptor (NCL-PGR-312). All stages were performed under the routine procedure of the hospital laboratory.

Inclusion Criteria:

  • Well stained paraffin embedded tissue specimens

Exclusion Criteria:

  • Fade away slides

Responsible Party: Tsafrir Kolatt, Applied Spectral Imaging Ltd. Identifier: NCT00978276     History of Changes
Other Study ID Numbers: ASI-IHC
First Posted: September 16, 2009    Key Record Dates
Last Update Posted: January 5, 2016
Last Verified: January 2016

Keywords provided by Applied Spectral Imaging Ltd.:
Over expression of Hormone receptors in carcinoma of the breast sues