Ignite Creation Date:
2024-05-06 @ 12:40 AM
Last Modification Date:
2024-10-26 @ 10:52 AM
Study NCT ID:
NCT01620853
Status:
COMPLETED
Last Update Posted:
2015-02-06
First Post:
2012-06-13
Brief Title:
Detection of Chromosomal Aberrations in Non-small Cell Lung Cancer NSCLC Using Fluorescent in Situ Hybridization FISH ALK Test
Sponsor:
Applied Spectral Imaging Ltd
Organization:
Applied Spectral Imaging Ltd
Study Overview
Official Title:
Concordance Study for Detection of Chromosomal Aberrations Using FISH ALK Testin Non-small Cell Lung Cancer NSCLC
Status:
COMPLETED
Status Verified Date:
2015-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None