NCT01066507

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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
126

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2008

Geographic Reach
2 countries

3 active sites

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

July 1, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 9, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 10, 2010

Completed
Last Updated

February 10, 2010

Status Verified

February 1, 2010

Enrollment Period

1.5 years

First QC Date

February 9, 2010

Last Update Submit

February 9, 2010

Conditions

Breast Cancer

Keywords

Her2FISHBreast cancerAmplification

Study Arms (1)

Breast cancer

Slides containing breast cancer paraffin embedded tissue sections.

Eligibility Criteria

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

You may qualify if:

  • Well stained breast tissue slides with bright Her2 signals

You may not qualify if:

  • Very old slides that were already bleached

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

PLUS Diagnostics

Lakewood, New Jersey, 08701, United States

Location

Scott & White Hospital, Texas

Temple, Texas, 76508, United States

Location

Sheba Medical Center, Pathology Dep.

Tel Aviv, Israel

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Paraffin embedded tissue sections

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Sheila Dobin, Ph.D.

    Section Chief, Cytogenetics

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 9, 2010

First Posted

February 10, 2010

Study Start

July 1, 2008

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

February 10, 2010

Record last verified: 2010-02

Locations

US(2)IL(1)