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

This study has been completed.
Information provided by (Responsible Party):
Applied Spectral Imaging Ltd. Identifier:
First received: June 13, 2012
Last updated: February 5, 2015
Last verified: February 2015

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.

Non-small Cell Lung Cancer (NSCLC)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Concordance Study for Detection of Chromosomal Aberrations Using FISH (ALK Test)in Non-small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:

Further study details as provided by Applied Spectral Imaging Ltd.:

Primary Outcome Measures:
  • IVD study [ Time Frame: 1 Day ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: May 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
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).

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients having non-small cell lung cancer (NSCLC)

Inclusion Criteria:

  • Well stained slides with bright FISH signals

Exclusion Criteria:

  • Very old slides that were already bleached
  Contacts and Locations
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Please refer to this study by its identifier: NCT01620853

United States, Texas
Scott & White Hospital,
Temple,, Texas, United States
Sponsors and Collaborators
Applied Spectral Imaging Ltd.
  More Information

No publications provided

Responsible Party: Applied Spectral Imaging Ltd. Identifier: NCT01620853     History of Changes
Other Study ID Numbers: ASI-ALK-F
Study First Received: June 13, 2012
Last Updated: February 5, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Applied Spectral Imaging Ltd.:
Non-small cell lung cancer (NSCLC)
ALK probe
Chromosomal aberrations

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Chromosome Aberrations
Chromosome Disorders
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Congenital Abnormalities
Genetic Diseases, Inborn
Lung Diseases
Neoplasms by Site
Pathologic Processes
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms processed this record on November 25, 2015