Identification and Semi-Quantification of Ki-67 Protein Expression Status

• Sponsor: Applied Spectral Imaging Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02654457
• Collaborator: (none)
• Enrollment: 3
• Duration (Months): 13

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Procedure: Women with Breast Cancer

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 Design

• Study Type: Observational
• Actual Enrollment: 3 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Identification and Semi-Quantification of Ki-67 Protein Expression Status in Formalin Fixed, Paraffin-embedded Normal and Neoplastic Breast Tissue
• Study Start Date: Dec 1, 2013
• Actual Primary Completion Date: May 1, 2014
• Actual Study Completion Date: Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Women with Breast Cancer #1 IVD Study	Procedure: Women with Breast Cancer; IVD Study
Women with Breast Cancer #2 IVD Study	Procedure: Women with Breast Cancer; IVD Study
Women with Breast Cancer #3 IVD Study	Procedure: Women with Breast Cancer; IVD Study

Outcome Measures

Primary Outcome Measures

1. IVD study of Ki67 IHC samples: Accuracy of analysis [1 Day]

   Comparison tests (accuracy) between manual and automatic analysis of antibody expressions. The results from the automatic counting from the clinical studies will be compared to the manual counting analysis. Accuracy of the study will be declared "Success" if Positive, Negative and Overall agreement with manual count of the Ki67 antibody at least 85%.

2. IVD study of Ki67 IHC samples: Repeatability & Reproducibility of analysis [1 Day]

   Repeatability & Reproducibility tests of system analysis of antibody expressions. R&R acceptance criteria of Ki67 are related to the average agreement for between runs, between days and between systems R&R part of the study will be declared "Success" if Positive and Negative average agreement will be at least 80%.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 89 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Slides with nuclear borders of tumor nuclei that is distinguishable, and having good integrity.

Exclusion Criteria:

• Slides that have lots of background that interfere with the analysis

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Applied Spectral Imaging Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Applied Spectral Imaging Ltd.
• ClinicalTrials.gov Identifier: NCT02654457
• Other Study ID Numbers: ASI-Ki-67-IHC
• First Posted: Jan 13, 2016
• Last Update Posted: Jan 13, 2016
• Last Verified: Jan 1, 2016

• Keywords provided by Applied Spectral Imaging Ltd.: Immunohistochemical; Ki-67; Breast cancer; IHC
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Jan 13, 2016