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

NCT00083512 | Recruiting

• 2 other identifiers: 04020004-C-0200
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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 Urine samples are collected in a cup and about 2 tablespoons of blood are withdrawn through a needle in a vein.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.

Conditions

Glioblastoma Multiforme

Keywords

Blood; Urine; GBM; Radiation; Natural History; Glioblastoma Multiforme

Outcome Measures

Primary Outcomes (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

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

  one year

Study Arms (1)

1/Glioblastoma multiforme patients

Patients with histologically confirmed supratentorial Glioblastoma multiforme

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients receiving radiation therapy for Glioblastoma multiforme (GBM). Primary clinical.

You may qualify if:

• 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.

You may not qualify if:

• 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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Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Kevin A Camphausen, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Theresa C Cooley Zgela, R.N.

CONTACT

(301) 451-8905; theresa.cooleyzgela@nih.gov

Kevin A Camphausen, M.D.

CONTACT

(240) 760-6205; camphauk@mail.nih.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2004
• First Posted: May 25, 2004
• Study Start: June 22, 2004
• Last Updated: April 16, 2026

Record last verified: 2026-04-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Clinical data available during the study and indefinitely.
• Access Criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.

Locations

US (1)