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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01620853
Recruitment Status : Completed
First Posted : June 15, 2012
Last Update Posted : February 6, 2015
Information provided by (Responsible Party):
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.

Condition or disease
Non-small Cell Lung Cancer (NSCLC)

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).

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Study Type : Observational
Actual Enrollment : 1 participants
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)
Study Start Date : May 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Primary Outcome Measures :
  1. IVD study [ Time Frame: 1 Day ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01620853

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

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Responsible Party: Applied Spectral Imaging Ltd. Identifier: NCT01620853    
Other Study ID Numbers: ASI-ALK-F
First Posted: June 15, 2012    Key Record Dates
Last Update Posted: February 6, 2015
Last Verified: February 2015
Keywords provided by Applied Spectral Imaging Ltd.:
Non-small cell lung cancer (NSCLC)
ALK probe
Chromosomal aberrations
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Chromosome Disorders
Chromosome Aberrations
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Pathologic Processes
Congenital Abnormalities
Genetic Diseases, Inborn