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| Sponsor: | National Institute of Neurological Disorders and Stroke (NINDS) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00071344 |
Purpose
This study will examine patients with non-small cell lung cancer metastasis, that is, the distant spreading of tumors to the brain, and compare them with patients without brain metastasis. The molecular and genetic events that permit tumor metastasis are not well understood. There is intense investigation going on into the process in which tumor cells escape the primary local tumor, spread to distant places in the body, and find and create conditions that promote growth in those tissues. Metastasis of tumors such as lung cancer to the brain is a common problem. Tumor cells will be analyzed with the use of microarrays. A microarray is a tool for analyzing gene expression, consisting of a small membrane or glass slide containing samples of many genes arranged in a regular pattern. The goal is to identify a potential molecular signature. It is hoped that there will be discovery of why some patients are more likely than others to develop a brain metastasis, which can have a major negative effect on the quality of life and survival.
Patients 18 years of age with known or evidence by radiology of a non-small cell lung cancer metastatic to the brain, either squamous cells or adenocarcinoma tumors, or those who have had a removal of a brain tumor for diagnosis or treatment may be eligible for this study.
Participants will undergo the following procedures and tests:
Patients will also undergo blood tests at 3-month intervals after surgery for up to 5 years. The purpose is to determine if there are tumor cells in the blood, which may explain how they reached the brain.
| Condition |
|---|
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Carcinoma, Non-Small -Cell Lung |
| Study Type: | Observational |
| Official Title: | Analysis of Brain Metastasis in Patients With Lung Cancer |
| Estimated Enrollment: | 78 |
| Study Start Date: | October 2003 |
| Estimated Study Completion Date: | October 2004 |
Introduction: The molecular and genetic events that permit tumor metastasis are not well understood. The process whereby tumor cells escape the primary, local tumor, spread to distant sites in the body and find and create conditions conducive to growth in these disparate tissues remains an area of intense investigation. Metastasis of epithelial tumors, such as lung cancer, to the brain is a common problem, with significant consequences with respect to neurological dysfunction and shortening of survival.
Objective: To study two subset of patients with non small cell lung cancer (NSCLC) metastatic to the brain, to identify genes and proteins that facilitate metastasis.
Study Population: 78 patients with NSCLC (n=39 squamous cell (SQ), and n=39 adenocarcinoma (AC) tumors) metastatic to the brain to compare with published microarray studies of non-metastatic NSCLC patients with these tumor types as well as with one another to help explain the differential trend toward metastasis in some patients with NSCLC and not others, as well as the differential trend to brain metastasis in the AC subtype.
Anticipated Risks and Benefits: Less than minimal risk to the patients to sample tissue already removed from the brain as part of medically-necessary surgery and to sample blood. No direct benefit to the patient is expected.
Outcome Estimate and Potential Meaning for the Field: That this very detailed investigation of the genes and proteins expressed differentially between the non-metastatic and metastatic NSCLCs, as well as between SQ and AC subtypes will identify new or previously-unsuspected targets for new therapies to either prevent the development of brain metastasis or to treat brain metastases more effectively.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Study ID Numbers: | 040004, 04-N-0004 |
| Study First Received: | October 20, 2003 |
| Last Updated: | March 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00071344 History of Changes |
| Health Authority: | United States: Federal Government |
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Microarray Genomics Trastuzumab Carcinoma Non-Small Cell Lung Cancer Metastatic Brain Tumor Brain |
Microarrays Microdissection Lung Cancer Non-Small Cell Lung Cancer NSCLC Metastatic Brain Tumor |
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Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Carcinoma Neoplasms Neoplastic Processes Pathologic Processes |
Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Lung Diseases Neoplasm Metastasis Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |