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

Non-small Cell Lung Cancer (NSCLC) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01620853
• Other study ID #: ASI-ALK-F
• Status: Completed
• Phase: N/A
• First received: June 13, 2012
• Last updated: February 5, 2015
• Start date: May 2012
• Est. completion date: January 2013

Study information

• Verified date: February 2015
• Source: Applied Spectral Imaging Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

Inclusion Criteria:

• Well stained slides with bright FISH signals

Exclusion Criteria:

• Very old slides that were already bleached

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Chromosome Aberrations
• Chromosome Disorders
• Lung Neoplasms
• Non-small Cell Lung Cancer (NSCLC)

Locations

Country	Name	City	State
United States	Scott & White Hospital,	Temple,	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Applied Spectral Imaging Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IVD study		1 Day	No