Recruiting

Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Glioblastoma Multiforme

Over 18 Years
+8 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

Summary

Principal SponsorNational Cancer Institute (NCI)
Study ContactTheresa C Cooley Zgela, R.N.
Last updated: September 30, 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.

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 Urine samples are collected in a cup and about 2 tablespoons of blood are withdrawn through a needle in a vein.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 * 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 
Principal SponsorNational Cancer Institute (NCI)
Study ContactTheresa C Cooley Zgela, R.N.
Last updated: September 30, 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
Glioblastoma Multiforme
Criteria
5 inclusion criteria required to participate
Age greater than or equal to 18 years.

Karnofsky performance \>60.

Histologically confirmed supratentorial Glioblastoma multiforme.

Ability of subject or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.


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.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Patients with histologically confirmed supratentorial Glioblastoma multiforme
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