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| ID | Type | Description | Link |
|---|---|---|---|
| 04-C-0200 |
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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 Urine samples are collected in a cup and about 2 tablespoons of blood are withdrawn through a needle in a vein.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.
BACKGROUND
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1/Glioblastoma multiforme patients | Patients with histologically confirmed supratentorial Glioblastoma multiforme |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | one year |
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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.
EXCLUSION CRITERIA:
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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Patients receiving radiation therapy for Glioblastoma multiforme (GBM). Primary clinical.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rukayat O Salau | Contact | (240) 858-3712 | rukayat.salau@nih.gov | |
| Kevin A Camphausen, M.D. | Contact | (240) 760-6205 | camphauk@mail.nih.gov |
| Name | Affiliation | Role |
|---|---|---|
| Kevin A Camphausen, M.D. | National Cancer Institute (NCI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center | Recruiting | Bethesda | Maryland | 20892 | United States |
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| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
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All IPD recorded in the medical record will be shared with intramural investigators upon request.
Clinical data available during the study and indefinitely.
Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |