Search / Trial NCT00001148

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

Launched by NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE (NINDS) · Nov 3, 1999

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Trial Information

Current as of July 14, 2024

Completed

Keywords

Metastasis Glioma Venous Sampling P53 Mutation Glioblastoma Multiforme Circulating Tumor Cells Mutation Anaplastic Astrocytoma

Description

Glioblastomas are the most frequent malignant brain tumor in adults and are widespread in the brain despite their discrete appearance on CT or MRI. While locally aggressive, metastasis of glioblastoma to extracranial organs is considered rare. Approximately 10% of patients with glioblastoma develop metastatic disease after radiation or craniotomy. Few patients have developed extracranial metastatic disease in the absence of surgical resection or radiation. Unlike tumors of other organs such as lung, colon and prostate, the presence of glioma cells in the circulation of patients undergoing s...

Gender

All

Eligibility criteria

  • INCLUSION CRITERIA:
  • Patients must be diagnosed with biopsy-proven glioblastoma multiforme or anaplastic astrocytoma (WHO grade III and IV, WHO classification of glial tumors) and meet the following criteria:
  • Consenting males and females between the ages of 18 and 75, inclusive.
  • Provided written informed consent prior to participation in the trial.
  • Karnofsky Performance Scale Score greater than or equal to 60.
  • Patients of all races and sexes are eligible for this study. Children and adolescents only rarely are afflicted with gliomas that are amenable for surgical resection, and so are excluded from this study.
  • Patients who have been accepted for glioma resection under existing NINDS protocols are also eligible for this study.
  • If tumor tissue is available from biopsy prior to surgery, we will attempt to identify tumor-specific mutation(s) prior to enrolling the patient.
  • EXCLUSION CRITERIA:
  • Clinically unstable condition.
  • Liver function impairment (total bilirubin greater than 2.0 mg/dl; AST or ALT greater than 3 times the upper limit of normal).
  • Coagulopathy (prothrombin time [PT] or activated partial thromboplastin time [APTT] > 1.5 times control).
  • Thrombocytopenia (platelet count less than 100,000/mm3).
  • Granulocytopenia (absolute neutrophil count less than 1,000/mm3).
  • Acute infection.
  • Acute medical problems.
  • Positive HIV test.
  • Karnofsky Performance Scale Score less than 60.
  • Allergy to CT contrast agents.
  • Absence of tumor-specific gene mutation.
  • Pregnant women. Women of child-bearing potential will undergo a urine and/or serum pregnancy test. Women who are pregnant will not be allowed to participate in this study.

Attachments

readout_NCT00001148_2024-07-14.pdf

4.5 MB

NCT00001148_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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