Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme
NCT ID: NCT00083512
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2004-06-22
Brief Summary
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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 Urine samples are collected in a cup and about 2 tablespoons of blood are withdrawn through a needle in a vein.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.
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Detailed Description
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* 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
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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1/Glioblastoma multiforme patients
Patients with histologically confirmed supratentorial Glioblastoma multiforme
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
Gliadel wafer placement at the time of surgery.
Pregnancy because radiation has the potential for teratogenic or abortifacient effects.
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18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Kevin A Camphausen, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute (NCI)
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, United States
Countries
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Central Contacts
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Facility Contacts
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For more information at the NIH Clinical Center contact National Cancer Institute Referral Office
Role: primary
Related Links
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NIH Clinical Center Detailed Web Page
Other Identifiers
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040200
Identifier Type: -
Identifier Source: org_study_id
NCT00087308
Identifier Type: -
Identifier Source: nct_alias
04-C-0200
Identifier Type: -
Identifier Source: secondary_id