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

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ClinicalTrials.gov Identifier: NCT00083512
Recruitment Status : Recruiting
First Posted : May 25, 2004
Last Update Posted : January 26, 2023
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

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 Urine samples are collected in a cup and about 2 tablespoons of blood are withdrawn through a needle in a vein.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


Condition or disease
Glioblastoma Multiforme

Detailed Description:

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 on 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 aide 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.
Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Urinary and Serum VEGF and MMP Levels in Patients Receiving Radiation Therapy for Glioblastoma Multiforme: Prospective Determination of a Predictive Value for Recurrence
Actual Study Start Date : June 22, 2004

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
1/Glioblastoma multiforme patients
Patients with histologically confirmed supratentorial Glioblastoma multiforme


Outcome Measures
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Primary Outcome Measures :
  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 [ Time Frame: one year ]
    Determine the whether VEGF and MMP level measurements aid in predicting tumor recurrence at 1 year.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients receiving radiation therapy for Glioblastoma multiforme (GBM). Primary clinical.
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 nonmelanomatous skin cancers or carcinoma in situ

Gliadel wafer placement at the time of surgery

Pregnant women are excluded from this study because radiation has the potential for teratogenic or abortifacient effects.

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Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00083512


Contacts
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Contact: Theresa Cooley-Zgela, R.N. (240) 764-6207 theresa.cooleyzgela@nih.gov
Contact: Kevin A Camphausen, M.D. (240) 760-6205 camphauk@mail.nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office    888-624-1937      
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Kevin A Camphausen, M.D. National Cancer Institute (NCI)
More Information
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Additional Information:

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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00083512    
Obsolete Identifiers: NCT00087308
Other Study ID Numbers: 040200
04-C-0200
First Posted: May 25, 2004    Key Record Dates
Last Update Posted: January 26, 2023
Last Verified: January 23, 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: .All IPD recorded in the medical record will be shared with intramural investigators upon request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Blood
Urine
GBM
 Radiation
Natural History
Glioblastoma Multiforme
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
 Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue