Gene-expression Profiles in CNS-metastatic Non-small Cell Lung Cancer

NCT00862173 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2012-06-12

No results posted yet for this study

Summary

Non small-cell lung cancer (NSCLC) accounts 85% of all lung cancer.The development of brain metastasis diminished life expectancy to less than one year with a median survival of less than three months. In NSCLC cancer, approximately 50% of patients with locally advanced disease develop brain metastasis at some time during the natural of disease. The central nervous system constitutes the first site of recurrence in 15 to 40% of these patients. Microarrays evaluate the diagnosis, treatment and prognosis of lung cancer.There are no studies that specifically evaluate the relationship between a genetic profile of NSCLC and metastasis to the CNS, with the purpose of distinguishing a subgroup of patients that will benefit of prophylactic treatment.What is the association between a genetic profile on NSCLC and the development of CNS metastasis.Obtaining a genetic profile from the primary NSCLC tumor cells, by using microarrays, we can predict the development of CNS metastasis arise a subgroup of patients that could benefit from prophylactic cranial radiation with which their quality of life and prognosis most probably will increase.Objective:Determine the association between a genetic profile from the primary tumor cells and the development of central nervous system metastasis in patients with non small-cell lung cancer.A genetic profile from the primary tumor cells are associated with the development of central nervous system metastasis in patients with NSCLC. A clinical, prospective, analytic, open, non randomized, prognostic and observational cohort with 66 patients with NSCLC who authorize a biopsy study from February, 2008 to December, 2012, INMEGEN institute will be in charge of performing the microarrays and the computer analysis in order to obtain the different genetic profiles that will be differentially expressed related with CNS metastasis risk profiles. Patients will be followed-up by means of the external consult of lung neoplasms. The statistical analysis will be performed using tests like Student's t or Mann-Whitney's U test. A multivariate analysis of logistic regression will be performed. Global survival time will be analyzed using Kaplan-Meier's technique and the comparison between groups will be performed with log-rank test. The adjustment for potential confusors will be performed using multivariate regression analysis. For result representation, we will use tables and graphs and pertinent measures will be taken to disclose the study.

Conditions

Sponsors & Collaborators

  • National Institute of Cancerología

    lead OTHER_GOV

Principal Investigators

  • David Saavedra-Pérez, MD · Instituto Nacional de Cancerologia de Mexico

  • Oscar Arrieta, MD · Instituto Nacional de Cancerologia de Mexico

  • Enrique Guzmán, MD · Instituto Nacional de Enfermedades Respiratorias

  • Gabriela Mercado, MSc · Instituto Nacional de Medicina Genómica

  • Elena Aréchaga, PhD · Instituto Nacional de Cancerologia de Mexico

  • Claudia González, PhD · Metropolitan Autonomous University

  • Digna Pachuca, MD · Instituto Nacional de Cancerologia de Mexico

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Mexico

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00862173 on ClinicalTrials.gov