Glioblastoma MultiformeNCT00083512
Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme
An observational study of Glioblastoma Multiforme, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This study will collect blood and urine samples from patients undergoing radiation therapy for glioblastoma multiforme (a type of brain tumor) to investigate the effects of this treatment on blood cells and certain proteins. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Glioblastoma Multiforme
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2004to not given
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving radiation therapy for Glioblastoma multiforme (GBM). Primary clinical.
Who may be able to join
- Age greater than or equal to 18 years.
- Histologically confirmed supratentorial Glioblastoma multiforme.
- Karnofsky performance >60.
- Patient must be a candidate for radiotherapy.
- Ability of subject or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.
Who cannot join
- Patients with other cancers excluding non-melanomatous skin cancers or carcinoma in situ.
- Gliadel wafer placement at the time of surgery.
- Pregnancy because radiation has the potential for teratogenic or abortifacient effects.
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Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact National Cancer Institute Referral Office, 888-624-1937
About this study
Official title: Urinary and Serum VEGF and MMP Levels in Patients Receiving Radiation Therapy for Glioblastoma Multiforme: Prospective Determination of a Predictive Value for Recurrence
This study will collect blood and urine samples from patients undergoing radiation therapy for glioblastoma multiforme (a type of brain tumor) to investigate the effects of this treatment on blood cells and certain proteins. The information from this study may help scientists develop new tests to measure radiation exposure and find new ways to treat cancer with radiation, and help determine which kinds of patients or tumors respond better to radiation therapy. Two proteins of particular interest in this study and which may be involved in the recurrence of cancer are VEGF (vascular endothelial growth factor) and MMPs (matrix metalloproteinases).
Patients 18 years of age and older with glioblastoma multiforme who are receiving or will receive radiation therapy as part of their medical treatment may be eligible for this study. Candidates are screened with a history and physical examination, blood tests, and magnetic resonance imaging (MRI) of the brain.
Participants will have blood and urine samples collected before, during and after completion of their radiation treatment. Urine samples are collected in a cup and about 2 tablespoons of blood are withdrawn through a needle in a vein. Additional samples may be requested at different times during treatment and in the 3-year follow-up period.
Read the detailed description
BACKGROUND
- Preliminary data generated from our pilot protocol 02-C-0064 suggests that the urinary VEGF and MMP level at the one month follow-up time point compared to the last on-treatment time point collection may be predictive of tumor recurrence at one year.
- Note that this preliminary study included patients with all histologies.
- In an ongoing effort to validate our results with a larger more homogeneous patient cohort we propose to prospectively study patients undergoing radiotherapy for GBM.
OBJECTIVES
-We will determine whether VEGF and MMP level measurements aid in predicting tumor recurrence at 1 year.
ELIGIBILITY
-Patients seen in the radiation oncology clinic will be asked to provide samples of blood and urine before, during and after their radiation treatment.
DESIGN
- This protocol-provides a means of acquiring blood and urine samples from patients receiving radiation therapy for Glioblastoma multiforme (GBM).
- Patients will be analyzed according to their Radiation Therapy Oncology Group (RTOG) recursive partitioning prognostic subgroups, which includes patient age, KPS, extent of resection and neurological function.
- Conditions
- Glioblastoma Multiforme
- Keywords
- Blood, Urine, GBM, Radiation, Natural History, Glioblastoma Multiforme
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1/Glioblastoma multiforme patients | Patients with histologically confirmed supratentorial Glioblastoma multiforme |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if an increase in urinary VEGF and MMP level, from the end of treatment to a patient's one-month follow-up examination following radiotherapy is predictive of one-year recurrence in patients with Glioblastoma multiforme
Determine the whether VEGF and MMP level measurements aid in predicting tumor recurrence at 1 year.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2004 (estimated)
- Study start22 Jun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Kevin A Camphausen, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00083512
- Sponsor's protocol ID
- 040200
- Other IDs
- 04-C-0200
- Status last verified
- 7 Aug 2026
- First submitted
- 25 May 2004
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD recorded in the medical record will be shared with intramural investigators upon request.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary and Serum VEGF and MMP Levels in Patients Receiving Radiation Therapy for Glioblastoma Multiforme: Prospective Determination of a Predictive Value for Recurrence
- ClinicalTrials.gov ID
- NCT00083512
- Acronym / sponsor ID
- 040200
- Conditions
- Glioblastoma Multiforme
- Keywords
- Blood, Urine, GBM, Radiation, Natural History, Glioblastoma Multiforme
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 22 Jun 2004 (actual)
- First posted
- 25 May 2004 (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.
This study will collect blood and urine samples from patients undergoing radiation therapy for glioblastoma multiforme (a type of brain tumor) to investigate the effects of this treatment on blood cells and certain proteins. The information from this study may help scientists develop new tests to measure radiation exposure and find new ways to treat cancer with radiation, and help determine which kinds of patients or tumors respond better to radiation therapy. Two proteins of particular interest in this study and which may be involved in the recurrence of cancer are VEGF (vascular endothelial growth factor) and MMPs (matrix metalloproteinases).
Patients 18 years of age and older with glioblastoma multiforme who are receiving or will receive radiation therapy as part of their medical treatment may be eligible for this study. Candidates are screened with a history and physical examination, blood tests, and magnetic resonance imaging (MRI) of the brain.
Participants will have blood and urine samples collected before, during and after completion of their radiation treatment. Urine samples are collected in a cup and about 2 tablespoons of blood are withdrawn through a needle in a vein. Additional samples may be requested at different times during treatment and in the 3-year follow-up period.
Detailed description
BACKGROUND
- Preliminary data generated from our pilot protocol 02-C-0064 suggests that the urinary VEGF and MMP level at the one month follow-up time point compared to the last on-treatment time point collection may be predictive of tumor recurrence at one year.
- Note that this preliminary study included patients with all histologies.
- In an ongoing effort to validate our results with a larger more homogeneous patient cohort we propose to prospectively study patients undergoing radiotherapy for GBM.
OBJECTIVES
-We will determine whether VEGF and MMP level measurements aid in predicting tumor recurrence at 1 year.
ELIGIBILITY
-Patients seen in the radiation oncology clinic will be asked to provide samples of blood and urine before, during and after their radiation treatment.
DESIGN
- This protocol-provides a means of acquiring blood and urine samples from patients receiving radiation therapy for Glioblastoma multiforme (GBM).
- Patients will be analyzed according to their Radiation Therapy Oncology Group (RTOG) recursive partitioning prognostic subgroups, which includes patient age, KPS, extent of resection and neurological function.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1/Glioblastoma multiforme patients | – | –Patients with histologically confirmed supratentorial Glioblastoma multiforme |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving radiation therapy for Glioblastoma multiforme (GBM). Primary clinical.
Key inclusion criteria (5 listed)
- Age greater than or equal to 18 years.
- Histologically confirmed supratentorial Glioblastoma multiforme.
- Karnofsky performance >60.
- Patient must be a candidate for radiotherapy.
- Ability of subject or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.
Key exclusion criteria (4 listed)
- Patients with other cancers excluding non-melanomatous skin cancers or carcinoma in situ.
- Gliadel wafer placement at the time of surgery.
- Pregnancy because radiation has the potential for teratogenic or abortifacient effects.
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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
To determine if an increase in urinary VEGF and MMP level, from the end of treatment to a patient's one-month follow-up examination following radiotherapy is predictive of one-year recurrence in patients with Glioblastoma multiforme
Time frame: one year
Determine the whether VEGF and MMP level measurements aid in predicting tumor recurrence at 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD recorded in the medical record will be shared with intramural investigators upon request.
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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.
Kevin A Camphausen, M.D. principal investigator
National Cancer Institute (NCI)
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 Glioblastoma Multiforme, run by National Cancer Institute (NCI) 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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 5 Nov 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rukayat O Salau ((240) 858-3712, rukayat.salau@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine if an increase in urinary VEGF and MMP level, from the end of treatment to a patient's one-month follow-up examination following radiotherapy is predictive of one-year recurrence in patients with Glioblastoma multiforme (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Nov 2026.