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.

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Key information

Conditions

Non-small Cell Lung Cancer (NSCLC) Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Chromosome Aberrations Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Scott & White Hospital,

Temple, Texas, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Well stained slides with bright FISH signals

Exclusion criteria

Very old slides that were already bleached

Treatment and study plan

Primary outcomes

IVD study

Time frame: 1 Day

Sponsors and collaborators

Lead sponsor

Applied Spectral Imaging Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Jun 15, 2012
Registry last updated: Feb 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed