Central Nervous SystemNCT00067067
Investigating Endothelial Precursor Cells (EPCs)
An observational study of Central Nervous System, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
Recent studies suggest that cells in the bone marrow-endothelial precursor cells (EPCs)-can provide a blood supply to cancerous tumors. The purpose of this study is to collect brain tumor and blood samples to look for these EPCs in the samples and analyze the growth signals that may help blood vessels to grow in… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Central Nervous System
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2003to Oct 2004
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Radiographic evidence of a primary glial neoplasm of the CNS (WHO grade II-IV) or any patient with a known primary neoplasm of the CNS.
- Medically indicated (diagnostic and/or therapeutic) tumor resection.
- Informed consent from patient, age 18 or older to 75 years of age.
- No racial or ethnic group or gender is excluded.
Who cannot join
- Inability to provide informed consent prior to surgery.
- Medical conditions that cannot be corrected prior to surgery that would be standard contraindications for neurosurgery.
- Pregnant Women: Women of child-bearing age will be tested before surgery for pregnancy.
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: Circulating Endothelial Progenitor Cells in Gliomas
Recent studies suggest that cells in the bone marrow-endothelial precursor cells (EPCs)-can provide a blood supply to cancerous tumors.
The purpose of this study is to collect brain tumor and blood samples to look for these EPCs in the samples and analyze the growth signals that may help blood vessels to grow in tumors. Researchers will study the following in the samples: 1) the number of blood vessels in the tumor; 2) the levels of growth factors in the tumor and blood; 3) the levels of circulating EPCs in the blood; and 4) the changes in the genes and proteins in the blood and tumor that influence growth factor levels.
Participants will be 18 years of age or older and have evidence of a brain tumor that requires surgery. From this surgery they will donate blood and tumor samples. Participants will have follow-up visits 4 to 8 weeks after surgery, then at 3-month intervals for two-and-one-half years, then at 6-month intervals thereafter. At these visits, participants will undergo a physical exam, a brain scan, and blood work.
Read the detailed description
Angiogenesis, or the development of new blood vessels, appears to be one of the keys to tumor survival. Areas of new blood vessel growth, or neovascularization, such as with trauma or tissue ischemia, appear to release factors that stimulate production of endothelial cells from progenitor stem cells located in the bone marrow. Endothelial cells for the inside lining of blood vessels are important in the formation of viable and functional blood vessel conduits. Recent work suggests that tumors-including primary brain tumors-secrete many of the same stimulatory growth factors as normally incite endothelial cells to be produced and turned out into the circulation. Initial evidence suggests that these circulating endothelial progenitor cells (EPCs) play a role in the impressive neovascularization seen with tumors. In this study, we wish to investigate the interaction of gliomas and EPCs to elucidate a potential role for EPCs in tumor formation, response to therapy, progression, and overall survival, as well, to identify potential new targets for anti-tumor and/or anti-angiogenic therapies using genomic and proteomic techniques.
Patients suspected of having, or with prior biopsy proof of, a WHO grade II-IV central nervous system (CNS) glial tumor(s) seen in the Surgical Neurology Branch, NINDS, will be considered for entry into this study. Tissue samples of tumor resected as part of standard care will be collected at surgery and preserved for research. Blood samples will also be collected. Blood will also be collected from anonymous normal volunteers who donate blood at the NIH Blood Bank; these anonymous donors will serve as controls.
- Conditions
- Central Nervous System
- Keywords
- Glioma, Brain Tumor, Endothelial Progenitor Cells
- Medical subject headings
- Glioma, Brain Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2003 (estimated)
- Study startAug 2003
- Study completionOct 2004
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 Central Nervous SystemStudies 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
- 84 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
- NCT00067067
- Sponsor's protocol ID
- 030269
- Other IDs
- 03-N-0269
- Status last verified
- Oct 2004
- First submitted
- 8 Aug 2003
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Louis DN, Pomeroy SL, Cairncross JG. Focus on central nervous system neoplasia. Cancer Cell. 2002 Mar;1(2):125-8. doi: 10.1016/s1535-6108(02)00040-5. No abstract available.
PubMed 12086870Maher EA, Furnari FB, Bachoo RM, Rowitch DH, Louis DN, Cavenee WK, DePinho RA. Malignant glioma: genetics and biology of a grave matter. Genes Dev. 2001 Jun 1;15(11):1311-33. doi: 10.1101/gad.891601. No abstract available.
PubMed 11390353Asahara T, Murohara T, Sullivan A, Silver M, van der Zee R, Li T, Witzenbichler B, Schatteman G, Isner JM. Isolation of putative progenitor endothelial cells for angiogenesis. Science. 1997 Feb 14;275(5302):964-7. doi: 10.1126/science.275.5302.964.
PubMed 9020076
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
- Circulating Endothelial Progenitor Cells in Gliomas
- ClinicalTrials.gov ID
- NCT00067067
- Acronym / sponsor ID
- 030269
- Conditions
- Central Nervous System
- Keywords
- Glioma, Brain Tumor, Endothelial Progenitor Cells
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Aug 2003
- Study completion
- Oct 2004
- First posted
- 11 Aug 2003 (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.
Recent studies suggest that cells in the bone marrow-endothelial precursor cells (EPCs)-can provide a blood supply to cancerous tumors.
The purpose of this study is to collect brain tumor and blood samples to look for these EPCs in the samples and analyze the growth signals that may help blood vessels to grow in tumors. Researchers will study the following in the samples: 1) the number of blood vessels in the tumor; 2) the levels of growth factors in the tumor and blood; 3) the levels of circulating EPCs in the blood; and 4) the changes in the genes and proteins in the blood and tumor that influence growth factor levels.
Participants will be 18 years of age or older and have evidence of a brain tumor that requires surgery. From this surgery they will donate blood and tumor samples. Participants will have follow-up visits 4 to 8 weeks after surgery, then at 3-month intervals for two-and-one-half years, then at 6-month intervals thereafter. At these visits, participants will undergo a physical exam, a brain scan, and blood work.
Detailed description
Angiogenesis, or the development of new blood vessels, appears to be one of the keys to tumor survival. Areas of new blood vessel growth, or neovascularization, such as with trauma or tissue ischemia, appear to release factors that stimulate production of endothelial cells from progenitor stem cells located in the bone marrow. Endothelial cells for the inside lining of blood vessels are important in the formation of viable and functional blood vessel conduits. Recent work suggests that tumors-including primary brain tumors-secrete many of the same stimulatory growth factors as normally incite endothelial cells to be produced and turned out into the circulation. Initial evidence suggests that these circulating endothelial progenitor cells (EPCs) play a role in the impressive neovascularization seen with tumors. In this study, we wish to investigate the interaction of gliomas and EPCs to elucidate a potential role for EPCs in tumor formation, response to therapy, progression, and overall survival, as well, to identify potential new targets for anti-tumor and/or anti-angiogenic therapies using genomic and proteomic techniques.
Patients suspected of having, or with prior biopsy proof of, a WHO grade II-IV central nervous system (CNS) glial tumor(s) seen in the Surgical Neurology Branch, NINDS, will be considered for entry into this study. Tissue samples of tumor resected as part of standard care will be collected at surgery and preserved for research. Blood samples will also be collected. Blood will also be collected from anonymous normal volunteers who donate blood at the NIH Blood Bank; these anonymous donors will serve as controls.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Radiographic evidence of a primary glial neoplasm of the CNS (WHO grade II-IV) or any patient with a known primary neoplasm of the CNS.
- Medically indicated (diagnostic and/or therapeutic) tumor resection.
- Informed consent from patient, age 18 or older to 75 years of age.
- No racial or ethnic group or gender is excluded.
Key exclusion criteria (3 listed)
- Inability to provide informed consent prior to surgery.
- Medical conditions that cannot be corrected prior to surgery that would be standard contraindications for neurosurgery.
- Pregnant Women: Women of child-bearing age will be tested before surgery for pregnancy.
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 12086870Louis DN, Pomeroy SL, Cairncross JG. Focus on central nervous system neoplasia. Cancer Cell. 2002 Mar;1(2):125-8. doi: 10.1016/s1535-6108(02)00040-5. No abstract available.
- Background: PubMed 11390353Maher EA, Furnari FB, Bachoo RM, Rowitch DH, Louis DN, Cavenee WK, DePinho RA. Malignant glioma: genetics and biology of a grave matter. Genes Dev. 2001 Jun 1;15(11):1311-33. doi: 10.1101/gad.891601. No abstract available.
- Background: PubMed 9020076Asahara T, Murohara T, Sullivan A, Silver M, van der Zee R, Li T, Witzenbichler B, Schatteman G, Isner JM. Isolation of putative progenitor endothelial cells for angiogenesis. Science. 1997 Feb 14;275(5302):964-7. doi: 10.1126/science.275.5302.964.
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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 Central Nervous System, 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 4 inclusion and 3 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 NCT00067067, 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.