Clinical trial · Observational
Gene-expression Profiles in CNS-metastatic Non-small Cell Lung Cancer
Gene-expression Profile as Predictor of Central Nervous System Metastasis Development in Non-small Cell Lung Cancer: a Prospective Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Disease | — | UNRESOLVED | — |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Patients with NSCLC with CNS Metastasis
- description
- Patients who developed CNS metastasis of NSCLC during the treatment.
- label
- Patients with NSCLC without CNS Metastasis
- description
- Patients with NSCLC that does not develop CNS metastasis during the treatment.
Primary outcomes (1)
- measure
- Central nervous system metastasis development
- timeFrame
- 8 months
Secondary outcomes (1)
- measure
- Death
- timeFrame
- 18 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available