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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Instituto Nacional de Cancerologia de Mexico
Sponsor:
Information provided by (Responsible Party):
Oscar Gerardo Arrieta Rodríguez MD, Instituto Nacional de Cancerologia de Mexico
ClinicalTrials.gov Identifier:
NCT01662635
First received: August 8, 2012
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

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.


Condition
Non Small-cell Lung Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: CLINICOPATHOLOGICAL FEATURES OF NON-SMALL CELL LUNG CANCER PATIENTS ASSOCIATED WITH THE CHOROMOSOME 2p (EML4-ALK) INVERSION IN MEXICAN POPULATION.

Resource links provided by NLM:


Further study details as provided by Instituto Nacional de Cancerologia de Mexico:

Primary Outcome Measures:
  • ALK rearragements for the hybritation FISH break apart (LSI-ALK) [ Time Frame: TWO YEARS ] [ Designated as safety issue: No ]
    The commercially labeled Vysis LSI ALK Dual Color (split-apart), break-apart rearrangement probe (Abbott Molecular, Abbott Park, IL) was used to detect any rearrangement involving the ALK gene. The probe hybridizes to band 2p23, on either side of the ALK gene breakpoint. Criteria for probe signal interpretation in at least 200 interphase nuclei were as follow: 1) separated green and orange signals or single red signals identified cells with rearranged ALK; 2) overlapping of red and green signals (yellowish) indicated cells in which ALK was not rearranged.


Biospecimen Retention:   Samples With DNA

To identify ALK rearrangements, fluorescence in situ hybridization (FISH) studies were performed on 3 to 4 microm thick paraffin sections from NSCLCs. Reverse transcription of total RNA was performed using High Capacity cDNA Archive Kit (Appied Biosystems, CA) each reaction containing 10 microg RNA, 1x RT buffer, 4 mM dNTP mix, 1x random hexamer primers, 50 U reverse transcriptase and 20 U RNAse inhibitor in a total volume of 100 microl.


Estimated Enrollment: 200
Study Start Date: February 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
POSITIVE ALK-BREAK APART

Detailed Description:

Lung adenocarcinoma studies. The only inclusion criterion was the availability of tissue for biomarker studies. To identify ALK rearrangements, fluorescence in situ hybridization (FISH) studies were performed on 3 to 4 mm thick paraffin sections from NSCLCs. The commercially labeled Vysis LSI ALK Dual Color (split-apart), break-apart rearrangement probe (Abbott Molecular, Abbott Park, IL) was used to detect any rearrangement involving the ALK gene. The probe hybridizes to band 2p23, on either side of the ALK gene breakpoint. Criteria for probe signal interpretation in at least 200 interphase nuclei were as follow: 1) separated green and orange signals or single red signals identified cells with rearranged ALK; 2) overlapping of red and green signals (yellowish) indicated cells in which ALK was not rearranged.

FISH-positive samples for ALK rearrangement were defined as having cells with a clearly separated pair of probe signals, or with >15% of cells having loss of the 5´(centromeric) probe. The higher threshold for loss is necessary because parts of probes can be lost during sectioning Clinical details of these patients were included in a database. Further results will be analyzed with the program SPSS17

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Mexican pupulation, with Non small-cell lung cancer.

Criteria

Inclusion Criteria:

  • The only inclusion criterion was the availability of tissue for biomarker studies.

Exclusion Criteria:

  • Disease Progression
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01662635

Contacts
Contact: Oscar Arrieta, MD +52 (55) 56280400 ext 832 ogarrieta@gmail.com
Contact: Graciela Cruz, PhD +52 (55) 56280400 ext 832 gracielacr@hotmail.com

Locations
Mexico
Instituto Nacional de Cancerologia Recruiting
Mexico, DF, Mexico, 14080
Contact: Oscar Arrieta, MD    +52 (55) 56280400 ext 832    ogarrieta@gmail.com   
Principal Investigator: Oscar Arrieta, MD         
Sponsors and Collaborators
Instituto Nacional de Cancerologia de Mexico
Investigators
Principal Investigator: Oscar Arrieta, MD Instituto de Cancerología
  More Information

No publications provided

Responsible Party: Oscar Gerardo Arrieta Rodríguez MD, MD and medical oncologist, Instituto Nacional de Cancerologia de Mexico
ClinicalTrials.gov Identifier: NCT01662635     History of Changes
Other Study ID Numbers: INCAN/CC/039/11
Study First Received: August 8, 2012
Last Updated: March 13, 2014
Health Authority: Mexico: Federal Commission for Sanitary Risks Protection

Keywords provided by Instituto Nacional de Cancerologia de Mexico:
Non-small cell lung cancer.
Diagnosis,
Adenocarcinoma,
ALK,
FISH,
Protein-tyrosine kinase

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms

ClinicalTrials.gov processed this record on October 01, 2014