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

This study is currently recruiting participants.
Verified May 2012 by Applied Spectral Imaging Ltd.
Sponsor:
Information provided by (Responsible Party):
Applied Spectral Imaging Ltd.
ClinicalTrials.gov Identifier:
NCT01620853
First received: June 13, 2012
Last updated: July 10, 2012
Last verified: May 2012
History of Changes
  Purpose

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
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:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

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

Estimated Enrollment: 160
Study Start Date: May 2012
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).

  Eligibility

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)

Criteria

Inclusion Criteria:

  • Well stained slides with bright FISH signals

Exclusion Criteria:

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

Contacts
Contact: Sheila Dobin,, Ph.D. 254-215-9031 SDOBIN@swmail.sw.org

Locations
United States, Texas
Scott & White Hospital, Recruiting
Temple,, Texas, United States
Contact: Shila Dobin, Ph.D     254-724-3704     SDOBIN@swmail.sw.org    
Principal Investigator: Shila Dobin, Ph.D            
Sponsors and Collaborators
Applied Spectral Imaging Ltd.
  More Information

No publications provided

Responsible Party: Applied Spectral Imaging Ltd.
ClinicalTrials.gov Identifier: NCT01620853     History of Changes
Other Study ID Numbers: ASI-ALK-F
Study First Received: June 13, 2012
Last Updated: July 10, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 21, 2013