NCT00083512 Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme
| NCT ID | NCT00083512 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Cancer Institute (NCI) |
| Condition | Glioblastoma Multiforme |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2004-06-22 |
| Primary Completion | — |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2004-06-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 Urine samples are collected in a cup and about 2 tablespoons of blood are withdrawn through a needle in a vein.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.
Eligibility Criteria
* 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. \<TAB\>\<TAB\>
Contact & Investigator
Kevin A Camphausen, M.D.
PRINCIPAL INVESTIGATOR
National Cancer Institute (NCI)
Frequently Asked Questions
Who can join the NCT00083512 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 120 Years, studying Glioblastoma Multiforme. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT00083512 currently recruiting?
Yes, NCT00083512 is actively recruiting participants. Contact the research team at rukayat.salau@nih.gov for enrollment information.
Where is the NCT00083512 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT00083512 clinical trial?
NCT00083512 is sponsored by National Cancer Institute (NCI). The principal investigator is Kevin A Camphausen, M.D. at National Cancer Institute (NCI). The trial plans to enroll 200 participants.
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