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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by National Institute of Cancerología.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
DR. MYRNA CANDELARIA, National Institute of Cancerología
ClinicalTrials.gov Identifier:
NCT00862173
First received: March 12, 2009
Last updated: June 11, 2012
Last verified: June 2012
  Purpose

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.


Condition
Brain Disease
Metastasis
Lung Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Gene-expression Profile as Predictor of Central Nervous System Metastasis Development in Non-small Cell Lung Cancer: a Prospective Study

Resource links provided by NLM:


Further study details as provided by National Institute of Cancerología:

Primary Outcome Measures:
  • Central nervous system metastasis development [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Death [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

NSCLC Biopsy.


Estimated Enrollment: 120
Study Start Date: March 2008
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with NSCLC with CNS Metastasis
Patients who developed CNS metastasis of NSCLC during the treatment.
Patients with NSCLC without CNS Metastasis
Patients with NSCLC that does not develop CNS metastasis during the treatment.

  Show Detailed Description

  Eligibility

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

Patients with confirmed or suggested diagnosis of non-small-cell lung cancer, consulting at the National Institutes of Cancerology or Respiratory Diseases (INCan, INER; Mexico City, Mexico)

Criteria

Inclusion Criteria:

  • Age > 18 years
  • With auto-sufficiency
  • Biopsy procedure approved
  • Any TNM status
  • Consulting at the National Institutes of Cancerology or Respiratory Diseases
  • Informed consent signed

Exclusion Criteria:

  • Comorbidity with other cancer type, hereditary or autoimmune diseases and treatment with immunosuppressor drugs
  • Previous treatment with adjuvant or neoadjuvant chemo- or radiotherapy
  • No specimen availability
  • No diagnosis of non-small-cell lung cancer at histopathology sample
  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: NCT00862173

Contacts
Contact: Oscar Arrieta, MD 01525556280400 ext 832 ogar@servidor.unam.mx
Contact: David Saavedra-Perez, MD 0152 5558634488 seelowen@msn.com

Locations
Mexico
Instituto Nacional de Enfermedades Respiratorias Recruiting
Mexico City, Mexico, 14080
Contact: Enrique Guzmán, MD    015255 56664539 ext 5120    enriqueg@prodigy.net.mx   
Sub-Investigator: Enrique Guzmán, MD         
Instituto Nacional de Cancerología Recruiting
Mexico City, Mexico, 14080
Contact: Oscar Arrieta, MD    015255 56280400 ext 832    ogar@servidor.unam.mx   
Principal Investigator: David Saavedra-Pérez, MD         
Sponsors and Collaborators
National Institute of Cancerología
Investigators
Principal Investigator: David Saavedra-Pérez, MD Instituto Nacional de Cancerología
Study Chair: Oscar Arrieta, MD Instituto Nacional de Cancerología
Study Director: Enrique Guzmán, MD Instituto Nacional de Enfermedades Respiratorias
Study Director: Gabriela Mercado, MSc Instituto Nacional de Medicina Genómica
Study Director: Elena Aréchaga, PhD Instituto Nacional de Cancerología
Study Director: Claudia González, PhD Metropolitan Autonomous University
Study Director: Digna Pachuca, MD Instituto Nacional de Cancerología
  More Information

No publications provided

Responsible Party: DR. MYRNA CANDELARIA, Gene expression Profiles in CNS metastasic Non small Cell Lung Cancer, National Institute of Cancerología
ClinicalTrials.gov Identifier: NCT00862173     History of Changes
Other Study ID Numbers: 008/025/OMI
Study First Received: March 12, 2009
Last Updated: June 11, 2012
Health Authority: Mexico: Ethics Committee

Keywords provided by National Institute of Cancerología:
Gene-expression profile
Central nervous system metastasis
Non-small-cell lung cancer

Additional relevant MeSH terms:
Neoplasm Metastasis
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Brain Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 16, 2014