AstrocytomaNCT00001148
Detecting Malignant Brain Tumor Cells in the Bloodstream During Surgery to Remove the Tumor
An observational study of Astrocytoma and Glioblastoma, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Astrocytoma, Glioblastoma, Glioma
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 1999to Jan 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, 20892
About this study
Official title: Detection of Glioblastoma or Anaplastic Astrocytoma Cells in the Circulation During Surgical Resection
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.
Read more
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 then be taken to the operating room for surgery. During surgery, not more than one quarter of a unit of blood will be removed through the catheter. The catheter will be removed before the patient enters the intensive care unit. Another MRI will be taken after surgery.
The study will enroll participants for 2 years. Patients will be followed at 3 months and 6 months after the surgery to make sure the postoperative period is uneventful.
Read the detailed 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 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.
- Conditions
- Astrocytoma, Glioblastoma, Glioma
- Keywords
- Metastasis, Glioma, Venous, Sampling, p53 Mutation, Glioblastoma Multiforme, Circulating Tumor Cells, Mutation, Anaplastic Astrocytoma
- Medical subject headings
- Astrocytoma, Glioblastoma, Glioma, Neoplasm Metastasis, Neoplastic Cells, Circulating
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startOct 1999
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AstrocytomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 25 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001148
- Sponsor's protocol ID
- 000009
- Other IDs
- 00-N-0009
- Status last verified
- Jan 2005
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Bernstein JJ, Woodard CA. Glioblastoma cells do not intravasate into blood vessels. Neurosurgery. 1995 Jan;36(1):124-32; discussion 132. doi: 10.1227/00006123-199501000-00016.
PubMed 7708148Brew BJ, Garrick R. Gliomas presenting outside the central nervous system. Clin Exp Neurol. 1987;23:111-7.
PubMed 2822301Chretien F, Gray F, Funalot B, Authier FJ, Peltier E, Lange F, Degos JD, Poirier J. [Extracerebral metastases of a glioblastoma, in the absence of surgery]. Arch Anat Cytol Pathol. 1995;43(5-6):342-9. French.
PubMed 8729851
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Glioblastoma or Anaplastic Astrocytoma Cells in the Circulation During Surgical Resection
- ClinicalTrials.gov ID
- NCT00001148
- Acronym / sponsor ID
- 000009
- Conditions
- Astrocytoma, Glioblastoma, Glioma
- Keywords
- Metastasis, Glioma, Venous, Sampling, p53 Mutation, Glioblastoma Multiforme, Circulating Tumor Cells, Mutation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Oct 1999
- Study completion
- Jan 2005
- First posted
- 4 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 then be taken to the operating room for surgery. During surgery, not more than one quarter of a unit of blood will be removed through the catheter. The catheter will be removed before the patient enters the intensive care unit. Another MRI will be taken after surgery.
The study will enroll participants for 2 years. Patients will be followed at 3 months and 6 months after the surgery to make sure the postoperative period is uneventful.
Detailed 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 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.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 7708148Bernstein JJ, Woodard CA. Glioblastoma cells do not intravasate into blood vessels. Neurosurgery. 1995 Jan;36(1):124-32; discussion 132. doi: 10.1227/00006123-199501000-00016.
- Background: PubMed 2822301Brew BJ, Garrick R. Gliomas presenting outside the central nervous system. Clin Exp Neurol. 1987;23:111-7.
- Background: PubMed 8729851Chretien F, Gray F, Funalot B, Authier FJ, Peltier E, Lange F, Degos JD, Poirier J. [Extracerebral metastases of a glioblastoma, in the absence of surgery]. Arch Anat Cytol Pathol. 1995;43(5-6):342-9. French.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Astrocytoma and Glioblastoma, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001148, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.