Detection of Circulating Glioblastoma or Anaplastic Astrocytoma Cells During Surgical Resection
This study aims to observe and detect the presence of circulating glioblastoma or anaplastic astrocytoma cells during your surgical resection.
Data Collection
Neoplasms+12
+ Neoplasms by Histologic Type
+ Neoplasms, Germ Cell and Embryonal
Summary
Study start date: October 1, 1999
Actual date on which the first participant was enrolled.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 surgical resection has not been established. If found absent, glioma cells may be unable to intravasate through the blood brain barrier. If present, these tumor cells presumably can intravasate but may be recognized and eliminated by an immunological process, or they may escape detection yet not be able to take hold in the new microenvironment. The information provided will add to the knowledge of the biology of these highly malignant tumors.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.25 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, United StatesOpen National Institute of Neurological Disorders and Stroke (NINDS) in Google Maps