Recruiting

Urinary and Serum VEGF and MMP Levels in Patients Receiving Radiation Therapy for Glioblastoma Multiforme: Prospective Determination of a Predictive Value for Recurrence

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Astrocytoma
+7

+ Glioblastoma
+ Glioma
Over 18 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: June 2004
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Study ContactTheresa C Cooley Zgela, R.N.More contacts
Last updated: December 27, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: June 22, 2004Actual date on which the first participant was enrolled.

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.

Official TitleUrinary and Serum VEGF and MMP Levels in Patients Receiving Radiation Therapy for Glioblastoma Multiforme: Prospective Determination of a Predictive Value for Recurrence 
NCT00087308NCT00083512
Principal SponsorNational Cancer Institute (NCI)
Study ContactTheresa C Cooley Zgela, R.N.More contacts
Last updated: December 27, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
200 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Cohort
These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

How participants are selected
Participants are selected without using randomization. They may be chosen based on convenience, access, or willingness to participate. This approach is common when random selection isn’t practical.
Another way to select participants is through a probability sample, where participants are chosen randomly, so everyone has an equal chance to be included.

How information is collected
Researchers start collecting data from the present day forward, following participants over time to observe outcomes. This approach helps identify how exposures or behaviors may lead to health events in the future.Other Ways to Collect Data
Retrospective: These studies use existing medical records or past data.
Cross-sectional: These studies collect data at one single point in time.
Others: Some studies use a mix of approaches or less common designs depending on the research goal.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Astrocytoma
Glioblastoma
Glioma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neoplasms, Neuroepithelial
Criteria
5 inclusion criteria required to participate
Age greater than or equal to 18 years.
Histologically confirmed supratentorial Glioblastoma multiforme.
Karnofsky performance \>60.
Patient must be a candidate for radiotherapy.

Show More Criteria

3 exclusion criteria prevent from participating
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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives

Determine the whether VEGF and MMP level measurements aid in predicting tumor recurrence at 1 year.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Recruiting
National Institutes of Health Clinical CenterBethesda, United StatesSee the location
Recruiting
One Study Center
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