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NCT00071383 · ClinicalTrials.gov registry record
Analysis of Brain Metastasis in Patients With Breast Cancer, With and Without Over-Expression of HER-2
A clinical trial, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- 78
- Enrollment target
NCT00071383 is a clinical trial that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 78 participants.
The verdict
NCT00071383 has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- 78 participants
- Enrollment target
Study Summary
This study will examine two subsets of patients with breast cancer metastasis, that is, spreading, to the brain. It will identify genes and proteins that promote metastasis, particularly in women who are found to over-express (have more than other people do) the human epidermal growth factor receptor, ErbB2, also known as HER-2. 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 breast 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. Female patients 18 years of age with known or evidence by radiology of a breast tumor metastatic to the brain 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: * Craniotomy, that is, surgical opening of the skull, and removal of the brain tumor. * Blood specimens taken from a central vein or artery before the operation, throughout as needed, and for several days afterward, to measure blood chemistries, blood count, and so forth. * Physical examination and imaging of the central nervous system before and after surgery. * Urine or serum, or both, pregnancy test of women of childbearing potential. Patients will also undergo blood tests at 3-month intervals after surgery for up to 5
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2003-10 |
| Est. Completion | 2004-11 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00071383
The ClinicalTrials.gov registry entry for NCT00071383 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 78 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT00071383 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00071383 about?
NCT00071383 is a clinical study titled "Analysis of Brain Metastasis in Patients With Breast Cancer, With and Without Over-Expression of HER-2". This study will examine two subsets of patients with breast cancer metastasis, that is, spreading, to the brain. It will identify genes and proteins that promote metastasis, particularly in women who are found to over-express (have more than other people do) the human epidermal growth factor recepto...
What is the current status of trial NCT00071383?
This trial is currently completed. The enrollment target is 78 participants. The study started on 2003-10. Estimated completion is 2004-11.
Who is sponsoring clinical trial NCT00071383?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
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