Concordance Study for Detection of Chromosomal Aberrations Using FISH (ALK Test)in Non-small Cell Lung Cancer (NSCLC)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Sponsor
- Applied Spectral Imaging Ltd.
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- IVD study
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief 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.
Detailed 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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Well stained slides with bright FISH signals
Exclusion Criteria
- •Very old slides that were already bleached
Outcomes
Primary Outcomes
IVD study
Time Frame: 1 Day