Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Mu… (NCT00083512) | Clinical Trial Compass
RecruitingNot Applicable
Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme
United States200 participantsStarted 2004-06-22
Plain-language 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 Urine samples are collected in a cup and about 2 tablespoons of blood are withdrawn through a needle in a vein.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.
Who can participate
Age range
18 Years – 120 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* INCLUSION CRITERIA:
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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Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is labeled 'Phase NA' and seems focused on collecting blood and urine samples rather than testing a new treatment — does participating in this study involve any changes to my standard radiation therapy for glioblastoma, or is it purely observational?
2The study is measuring levels of VEGF and MMP in my urine to see if they can predict tumor recurrence at one year — could you explain what VEGF and MMP are, and whether tracking these markers might give us any useful early warning information about my specific situation?
3Since this trial involves collecting samples during and after radiotherapy, how many additional visits or sample collections would be required beyond what my regular treatment schedule already involves, and is that realistic given everything else I'll be managing?
4Given that this is a sample collection study and not testing a new drug or therapy, would joining this trial have any direct benefit for me personally, or is the value mainly for future glioblastoma patients and research?
5Are there other trials or standard treatment approaches I should be weighing alongside or instead of this one, and would participating here in any way affect my eligibility for other studies that might offer a more direct treatment benefit?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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