Clinicopathological Features of NSCLC Patients Associated With the Chromosome 2p (EML4-ALK)
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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. |
- 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 |
| 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 |
Mexican pupulation, with Non small-cell lung cancer.
Inclusion Criteria:
- The only inclusion criterion was the availability of tissue for biomarker studies.
Exclusion Criteria:
- Disease Progression
Contacts and Locations| Contact: Oscar Arrieta, MD | +52 (55) 56280400 ext 832 | ogarrieta@gmail.com |
| Contact: Graciela Cruz, PhD | +52 (55) 56280400 ext 832 | gracielacr@hotmail.com |
| 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 | |
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: | August 9, 2012 |
| 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:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms |
Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 16, 2013