NCT02654457

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 5, 2015

Completed
11 months until next milestone

First Posted

Study publicly available on registry

January 13, 2016

Completed
Last Updated

January 13, 2016

Status Verified

January 1, 2016

Enrollment Period

5 months

First QC Date

February 5, 2015

Last Update Submit

January 12, 2016

Conditions

Breast Cancer

Keywords

ImmunohistochemicalKi-67Breast cancerIHC

Outcome Measures

Primary Outcomes (2)

  • IVD study of Ki67 IHC samples: Accuracy of analysis

    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%.

    1 Day

  • IVD study of Ki67 IHC samples: Repeatability & Reproducibility of analysis

    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%.

    1 Day

Study Arms (3)

Women with Breast Cancer #1

IVD Study

Procedure: Women with Breast Cancer

Women with Breast Cancer #2

IVD Study

Procedure: Women with Breast Cancer

Women with Breast Cancer #3

IVD Study

Procedure: Women with Breast Cancer

Interventions

Women with Breast CancerPROCEDURE

IVD Study

Women with Breast Cancer #1Women with Breast Cancer #2Women with Breast Cancer #3

Eligibility Criteria

Age21 Years - 89 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Women having breast cancer aged 21 and up

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2015

First Posted

January 13, 2016

Study Start

December 1, 2013

Primary Completion

May 1, 2014

Study Completion

January 1, 2015

Last Updated

January 13, 2016

Record last verified: 2016-01