Detection of Chromosomal Aberrations in Non-small Cell Lung Cancer (NSCLC) Using Fluorescent in Situ Hybridization (FISH) (ALK Test)
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.
Non-small Cell Lung Cancer (NSCLC)
|Study Design:||Observational Model: Cohort
Time Perspective: Retrospective
|Official Title:||Concordance Study for Detection of Chromosomal Aberrations Using FISH (ALK Test)in Non-small Cell Lung Cancer (NSCLC)|
- IVD study [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
|Study Start Date:||May 2012|
|Study Completion Date:||January 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01620853
|United States, Texas|
|Scott & White Hospital,|
|Temple,, Texas, United States|