Clinicopathological Features of NSCLC Patients Associated With the Chromosome 2p (EML4-ALK)

NCT01662635 | Completed Results

• 1 other identifier: INCAN/CC/039/11
• Study Type: observational
• Target: 230
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non Small-cell Lung Cancer

Keywords

Non-small cell lung cancer.; Diagnosis,; Adenocarcinoma,; ALK,; FISH,; IHC; RT-qPCR

Outcome Measures

Primary Outcomes (1)

• FISH, IHC, RT-qPCR Comparison

  200 samples underwent FISH, from them 63 underwent IHC and 48 RT-qPCR.

  TWO YEARS

Study Arms (1)

ALK-BREAK APART

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Mexican pupulation, with Non small-cell lung cancer.

You may not qualify if:

• Disease Progression

Sponsors & Collaborators

• Instituto Nacional de Cancerologia de Mexico: lead

Study Sites (1)

Instituto Nacional de Cancerologia

Mexico City, Mexico City, 14080, Mexico

Location

Related Publications (1)

• 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.

  BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Disease; Adenocarcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Limitations and Caveats

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.

Results Point of Contact

• Title: Oscar Gerardo Arrieta-Rodríguez
• Organization: Thoracic Oncology Unit. Instituto Nacional de Cancerología

ogar@unam.mx

+52 55 56280400

Study Officials

• Oscar Arrieta, MD

  Instituto de Cancerología

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD and medical oncologist

Study Record Dates

• First Submitted: August 8, 2012
• First Posted: August 10, 2012
• Study Start: February 1, 2011
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: January 9, 2019
• Results First Posted: November 21, 2014

Record last verified: 2016-08

Locations

ME (1)