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Detection of Amplification of Her2 Fluorescent in Situ Hybridization (FISH) in Breast Tissue Sections

Concordance Study for Amplification Detection of Her2 FISH in Breast Tissue Sections

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01066507
Acronym
Her2F test
Enrollment
126
Registered
2010-02-10
Start date
2008-07-31
Completion date
2010-01-31
Last updated
2010-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Her2, FISH, Breast cancer, Amplification

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.

Interventions

None listed

Sponsors

Applied Spectral Imaging Ltd.
Lead SponsorINDUSTRY

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Well stained breast tissue slides with bright Her2 signals

Exclusion criteria

* Very old slides that were already bleached

Countries

Israel, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026