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Clinical Trial Summary

The purpose of the study is the identification of chromosomal aberrations in non-small cell lung cancer (NSCLC) .

The imaging system is intended for diagnostic use as an aid to the pathologist in the detection, counting and classifying ALK FISH stained lung samples.


Clinical Trial Description

The ALK Break Apart FISH test detects chromosomal aberrations via fluorescence in situ hybridization (FISH) in formalin-fixed paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tissue specimens. The FDA approved ALK kit is designed to detect rearrangements involving the ALK gene (2p23). Results from the ALK Kit are intended for use, in conjunction with and not in lieu of current standard diagnostic procedures, as an aid for the pathologist in the identification of patients eligible for treatment with XALKORI® (crizotinib). ;


Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


NCT number NCT01620853
Study type Observational
Source Applied Spectral Imaging Ltd.
Contact
Status Completed
Phase N/A
Start date May 2012
Completion date January 2013

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