Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00083512
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2004-05-25
Brief Title:
Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-09-26
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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after completion of their radiation treatment Urine samples are collected in a cup and about 2 tablespoons of blood are withdrawn through a needle in a vein Additional samples may be requested at different times during treatment and in the 3-year follow-up period
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 04-C-0200 | None | None | None |