Gene-expression Profiles in CNS-metastatic Non-small Cell Lung Cancer
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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 |
- Central nervous system metastasis development [ Time Frame: 8 months ] [ Designated as safety issue: No ]
- 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 |
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)
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| Contact: Oscar Arrieta, MD | 01525556280400 ext 832 | ogar@servidor.unam.mx |
| Contact: David Saavedra-Perez, MD | 0152 5558634488 | seelowen@msn.com |
| 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 | |
| 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:
|
Brain Diseases Carcinoma, Non-Small-Cell Lung Lung Neoplasms Neoplasm Metastasis Central Nervous System Diseases Nervous System Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |
Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Neoplastic Processes Pathologic Processes |
ClinicalTrials.gov processed this record on May 19, 2013