- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01066507
Detection of Amplification of Her2 Fluorescent in Situ Hybridization (FISH) in Breast Tissue Sections (Her2F test)
February 9, 2010 updated by: Applied Spectral Imaging Ltd.
Concordance Study for Amplification Detection of Her2 FISH in Breast Tissue Sections
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
126
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tel Aviv, Israel
- Sheba Medical Center, Pathology Dep.
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New Jersey
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Lakewood, New Jersey, United States, 08701
- PLUS Diagnostics
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Texas
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Temple, Texas, United States, 76508
- Scott & White Hospital, Texas
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability 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
Description
Inclusion Criteria:
- Well stained breast tissue slides with bright Her2 signals
Exclusion Criteria:
- Very old slides that were already bleached
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
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Breast cancer
Slides containing breast cancer paraffin embedded tissue sections.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Sheila Dobin, Ph.D., Section Chief, Cytogenetics
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2008
Primary Completion (Actual)
January 1, 2010
Study Completion (Actual)
January 1, 2010
Study Registration Dates
First Submitted
February 9, 2010
First Submitted That Met QC Criteria
February 9, 2010
First Posted (Estimate)
February 10, 2010
Study Record Updates
Last Update Posted (Estimate)
February 10, 2010
Last Update Submitted That Met QC Criteria
February 9, 2010
Last Verified
February 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ASI-Her2F
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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