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

NCT00862173 | Unknown

• 1 other identifier: 008/025/OMI
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 2

Brief 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

Brain Disease; Metastasis; Lung Cancer

Keywords

Gene-expression profile; Central nervous system metastasis; Non-small-cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Central nervous system metastasis development

  8 months

Secondary Outcomes (1)

• Death

  18 months

Study Arms (2)

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.

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

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)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Cancerología: lead

Study Sites (2)

Instituto Nacional de Cancerología

Mexico City, 14080, Mexico

RECRUITING

Instituto Nacional de Enfermedades Respiratorias

Mexico City, 14080, Mexico

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

NSCLC Biopsy.

MeSH Terms

Conditions

Brain Diseases; Neoplasm Metastasis; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Officials

• David Saavedra-Pérez, MD

  Instituto Nacional de Cancerologia de Mexico

  PRINCIPAL INVESTIGATOR

• Oscar Arrieta, MD

  Instituto Nacional de Cancerologia de Mexico

  STUDY CHAIR

• 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 Cancerologia de Mexico

  STUDY DIRECTOR

• Claudia González, PhD

  Metropolitan Autonomous University

  STUDY DIRECTOR

• Digna Pachuca, MD

  Instituto Nacional de Cancerologia de Mexico

  STUDY DIRECTOR

Central Study Contacts

Oscar Arrieta, MD

CONTACT

01525556280400; ogar@servidor.unam.mx

David Saavedra-Perez, MD

CONTACT

0152 5558634488; seelowen@msn.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gene expression Profiles in CNS metastasic Non small Cell Lung Cancer

Study Record Dates

• First Submitted: March 12, 2009
• First Posted: March 16, 2009
• Study Start: March 1, 2008
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 12, 2012

Record last verified: 2012-06

Locations

ME (2)