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

Concordance Study for Detection of Chromosomal Aberrations Using FISH (ALK Test)in Non-small Cell Lung Cancer (NSCLC)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01620853

Enrollment

Registered

2012-06-15

Start date

2012-05-31

Completion date

2013-01-31

Last updated

2015-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer (NSCLC)

Keywords

Non-small cell lung cancer (NSCLC), ALK probe, FISH, Chromosomal aberrations

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 90 Years

Healthy volunteers

Inclusion criteria

* Well stained slides with bright FISH signals

Exclusion criteria

* Very old slides that were already bleached

Design outcomes

Primary

Measure	Time frame
IVD study	1 Day

Countries

United States

Outcome results