Sponsor study identifier
observational
230
1 country
1
Study Start
February 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2014
Actual (reported)Study Completion
September 2014
Actual (reported)Because ALK-positive lung cancer constitutes less than 5% of all lung cancers, it is critically important to select those patients who are more likely to have the ALK mutation. Clinical characteristics of patients with mutations in the target gene should also be known, so that the incidence of a given target mutation is established in a specific population. There is not incidence known in Mexican population, but it is believed it is greater.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2014
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2011
Date type not reportedThis date has not been verified as actual or estimated.
August 8, 2012
Actual (reported)August 10, 2012
Actual (reported)September 2014
Actual (reported)September 2014
Actual (reported)November 21, 2014
Actual (reported)FISH, IHC, RT-qPCR Comparison
200 samples underwent FISH, from them 63 underwent IHC and 48 RT-qPCR.
TWO YEARS
We reviewed 230 consecutive cases of NSCLC that were retrieved from oncologic molecular laboratory and diagnostic pathology unit at the Instituto Nacional de Cancerologia, Mexico city, between 2011 and 2014. Samples were sent to the unit of pathological anatomy, a Pathologist confirmed the histologic diagnosis. The only inclusion criterion was the availability of tissue for biomarker studies. Clinical and pathologic details of these patients were included in a database, obtained from medical records. For ALK fusion testing, we applied dual-color, break-apart FISH, RT-qPCR, and immunohistochemistry. Interpretation of the results was done in double-blind manner without knowing the results by other methods.
Mexican pupulation, with Non small-cell lung cancer.
Contact the study team to confirm eligibility.
Instituto Nacional de Cancerologia
Mexico City, Mexico City, 14080, Mexico
Jemal A, Freddie Bray, Melissa M, et al. Cancer statistics, 2011. CA Cancer J Clin. 61: 69-90, 2011. Wong DW. The EML4-ALK Fusion Gene Is Involved in Various Histologic Types of Lung Cancers From Non smokers With Wild-type EGFR and KRAS. Cancer 15, 1723-1733, 2009. Shaw, A. T. et al. Clinical Features and outcome of patients with non-small-cell lung cancer who harbor EML4-ALK. J. Clin. Oncol. 27, 4247-4253 2009. Kwak, E. L. et al. Anaplatic lymphoma kinase Inhibition in non-small cell lung cancer. N. Engl. J. Med. 363, 1693- 1703 2010. Soda M., Takada, S., Takeuchi, K., Choi, Y.L., Enomoto, M., Ueno, T. et al. A mouse model for EML4-ALK- positive lung cáncer. Proc Natl Acad Sci U S A 105: 19893-19897, 2008.
FISH studies were performed in 3-mm to 4-mm thick paraffin sections from 230 NSCLCs and 1 ALCL specimen with t(2;5) that was used as a positive control for the break-apart detection. 48 patients were analyzed for the presence of EML4-ALK gene fusion variants using the RNA from frozen tissue sections
There were no limitations in obtaining the planned number of samples. Two-hundred and thirty patients with advanced NSCLC were analyzed by FISH. Among the FISH tests performed, 30 were not evaluable due to scarce samples.
Oscar Arrieta, MD
Instituto de Cancerología
230 participants (actual enrollment reported by the registry).
First Submitted
August 8, 2012
First Posted
August 10, 2012
Study Start
February 2011
Date type not reportedThis date has not been verified as actual or estimated.
Frequency of EGFR Mutations in Latinos/Hispanics With Non-Small Cell Lung Cancer
Primary Completion
September 2014
Actual (reported)Study Completion
September 2014
Actual (reported)Last Updated
January 9, 2019
Results First Posted
November 21, 2014
Record last verified: 2016-08
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Source: ClinicalTrials.gov.
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