Detection of Chromosomal Aberrations in Non-small Cell Lung Cancer (NSCLC) Using Fluorescent in Situ Hybridization (FISH) (ALK Test)

Completed

• Conditions: Non-small Cell Lung Cancer (NSCLC)

• Registration Number: NCT01620853
• Lead Sponsor: Applied Spectral Imaging Ltd.

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).

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-06-13
• Study First Submitted QC: 2012-06-13
• Study First Posted: 2012-06-15
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-05
• Last Update Posted: 2015-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• Well stained slides with bright FISH signals

Exclusion Criteria

• Very old slides that were already bleached

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
IVD study	1 Day

Trial Locations

Locations (1)

Scott & White Hospital,; 🇺🇸 Temple,, Texas, United States