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NCT00001148 · ClinicalTrials.gov registry record

Detecting Malignant Brain Tumor Cells in the Bloodstream During Surgery to Remove the Tumor

A clinical trial, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).

Completed
Registry status
25
Enrollment target

NCT00001148: Completed study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).

NCT00001148 is a clinical trial that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 25 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00001148 has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).

COMPLETED
Registry status
25 participants
Enrollment target

Study Summary

Glioblastomas, the most frequent malignant brain tumor in adults, are widespread in the brain, despite their discrete appearance on computed tomography (CT) or magnetic resonance imaging (MRI). While this tumor tends to spread widely in the brain, unlike other tumors of the body, it rarely metastasizes, or spreads, to other organs. Approximately 10 percent of patients with glioblastoma develop metastatic disease after radiation or brain surgery. In the absence of radiation or brain surgery, few patients have developed disease spread outside the brain. During surgery to remove tumors of other organs of the body, such as the lung, prostate, kidney, or ovary, cells from these tumors are routinely found in the bloodstream. These cells are believed to be the reason for the spread of these tumors. In the case of malignant brain tumors, this process of glioma (tumor) cells shedding into circulation has not yet been investigated. This study will determine whether glioma cells can be detected in the bloodstream of patients undergoing surgery. If glioma cells are absent, it may mean they are unable to penetrate the blood-brain barrier. If they are present, they presumably can penetrate into blood vessels but they may be recognized and eliminated by the immune system, or they may escape detection yet not be able to take hold in the new microenvironment. The results of the study will add to the knowledge of the biology of these highly malignant tumors. Study participants will be admitted to the hospital for 8 to 10 days. They will undergo a complete physical and neurological exam and blood and urine tests. An electrocardiogram will be performed, and x-rays may be taken. On the morning of surgery, the patient will receive sedation intravenously. A tiny plastic tube called a catheter will be introduced into a vein in the groin through needles. The catheter will be passed through to the jugular bulb, right above the jugular vein, on the same side as the tumor. The patient will

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 1999-10
Est. Completion 2005-01

What the finished NCT00001148 record still lists

NCT00001148 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 25 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT00001148 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00001148 about?

NCT00001148 is a clinical study titled "Detecting Malignant Brain Tumor Cells in the Bloodstream During Surgery to Remove the Tumor". Glioblastomas, the most frequent malignant brain tumor in adults, are widespread in the brain, despite their discrete appearance on computed tomography (CT) or magnetic resonance imaging (MRI). While this tumor tends to spread widely in the brain, unlike other tumors of the body, it rarely metastasi...

What is the current status of trial NCT00001148?

This trial is currently completed. The enrollment target is 25 participants. The study started on 1999-10. Estimated completion is 2005-01.

Who is sponsoring clinical trial NCT00001148?

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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Source: ClinicalTrials.gov NCT00001148, the US trial registry maintained by the National Library of Medicine. NCT00001148 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.