Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-29 @ 3:00 AM
Study NCT ID:
NCT02654457
Status:
COMPLETED
Last Update Posted:
2016-01-13
First Post:
2015-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Identification and Semi-Quantification of Ki-67 Protein Expression Status
Sponsor:
Applied Spectral Imaging Ltd.
Organization:
Study Overview
Official Title:
Identification and Semi-Quantification of Ki-67 Protein Expression Status in Formalin Fixed, Paraffin-embedded Normal and Neoplastic Breast Tissue
Status:
COMPLETED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is the identification and semi-quantification of Ki-67 protein expression level in breast cancer tissues by the GenASIs GoPth system as compared to manual reading of the same slides.
The imaging system is intended for diagnostic use as an aid to the pathologist in the detection, counting and classifying ER/PR IHC stained samples
The imaging system is intended for diagnostic use as an aid to the pathologist in the detection, counting and classifying ER/PR IHC stained samples
Detailed Description:
The anti Ki-67 is a semi-quantitative immunohistochemical (IHC) assay to identify the Ki-67 protein expressions in formalin-fixed, paraffin-embedded human breast cancer tissue specimens. Results from the Ki-67 test is indicated as an aid in the assessment of the protein status of breast cancer patients. While the p53 kit provides the antibody that offer direct visualization and semi-quantification of the protein expression through a brightfield microscope, the GenASIs GoPath system is designed to complement the routine workflow of the pathologist in the analysis and review of immunohistochemically stained histologic slides.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: