Recruiting

Observational Study

Sponsor:

National Cancer Institute (NCI)

Code:

NCT00083512

Conditions

Glioblastoma Multiforme

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

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 Urine samples are collected in a cup and about 2 tablespoons of blood are withdrawn through a needle in a vein.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

Study ID

NCT00083512

Start date

Jun 22, 2004

Status verified date

Aug 7, 2026

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

  • 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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Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

1/Glioblastoma multiforme patients

Patients with histologically confirmed supratentorial Glioblastoma multiforme

Primary outcome measure

  • 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 [ Time Frame: one year ]

Central Contacts and Locations

Central contacts

Rukayat O Salau

(240) 858-3712rukayat.salau@nih.gov

Kevin A Camphausen, M.D.

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

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact National Cancer Institute Referral Office

888-624-1937

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Aug 11, 2026

Last verified

Aug 7, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Cancer Institute (NCI) on 2026-08-11.