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NCT00059020 · ClinicalTrials.gov registry record
The Role of Gene Changes in Brain Tumor Formation and Growth
A clinical trial, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- 344
- Enrollment target
NCT00059020 is a clinical trial that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 344 participants.
The verdict
NCT00059020 has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- 344 participants
- Enrollment target
Study Summary
This study will examine tissue from gliomas (a type of brain tumor) removed during surgery for gene mutations, or changes, thought to be involved in tumor formation and growth. One common gene mutation causes the receptor for a protein called epidermal growth factor (EGF) to be in an active state all of the time, allowing uncontrolled cell growth that can lead to tumor formation. This study will analyze blood and tumor tissue samples from patients with gliomas for: * Changes in the EGF gene in the tumor * Changes in other genes, such as that for the EGF receptor (EGFR) * Changes in levels of EGF and EGFR, and in other proteins and genes that respond to changes in the levels of these proteins in the tumor * Changes in the EGF gene and protein in the blood The study will also determine if production of EGF and EGFR obtained from glioma and from blood cells derived from the tumor can be altered in the laboratory to grow indefinitely in culture. Patients between 18 and 75 years of age with a brain tumor that requires surgical treatment may be eligible for this study. Participants will be admitted to the NIH Clinical Center for about 3 to 10 days. They will have a physical and neurological examination, blood and urine tests, other tests, if medically necessary, and will be evaluated and prepared for surgery. During surgery, as much of the tumor as possible will be removed. A small amount of the tumor tissue will be collected for this study. No tissue will be removed for this study that would not otherwise have been removed. Some of the tissue will be used to culture glioma cells and the rest will be frozen and stored for examination, as described above. If any normal-appearing brain tissue is removed during surgery in order to enhance safety in removing the tumor, the normal tissue will be studied as well. Brain tissue that appears normal will not be removed strictly for research. During surgery and the day after surgery, a blood sample will be drawn from a catheter
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 344 participants |
| Start Date | 2003-04 |
| Est. Completion | 2004-11 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00059020
The ClinicalTrials.gov registry entry for NCT00059020 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 344 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.
NCT00059020 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00059020 about?
NCT00059020 is a clinical study titled "The Role of Gene Changes in Brain Tumor Formation and Growth". This study will examine tissue from gliomas (a type of brain tumor) removed during surgery for gene mutations, or changes, thought to be involved in tumor formation and growth. One common gene mutation causes the receptor for a protein called epidermal growth factor (EGF) to be in an active state al...
What is the current status of trial NCT00059020?
This trial is currently completed. The enrollment target is 344 participants. The study started on 2003-04. Estimated completion is 2004-11.
Who is sponsoring clinical trial NCT00059020?
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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