NCT00067067

Brief Summary

Recent studies suggest that cells in the bone marrow-endothelial precursor cells (EPCs)-can provide a blood supply to cancerous tumors. The purpose of this study is to collect brain tumor and blood samples to look for these EPCs in the samples and analyze the growth signals that may help blood vessels to grow in tumors. Researchers will study the following in the samples: 1) the number of blood vessels in the tumor; 2) the levels of growth factors in the tumor and blood; 3) the levels of circulating EPCs in the blood; and 4) the changes in the genes and proteins in the blood and tumor that influence growth factor levels. Participants will be 18 years of age or older and have evidence of a brain tumor that requires surgery. From this surgery they will donate blood and tumor samples. Participants will have follow-up visits 4 to 8 weeks after surgery, then at 3-month intervals for two-and-one-half years, then at 6-month intervals thereafter. At these visits, participants will undergo a physical exam, a brain scan, and blood work.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

August 8, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 11, 2003

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2004

Completed
Last Updated

March 4, 2008

Status Verified

October 1, 2004

First QC Date

August 8, 2003

Last Update Submit

March 3, 2008

Conditions

Keywords

GliomaBrain TumorEndothelial Progenitor Cells

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Radiographic evidence of a primary glial neoplasm of the CNS (WHO grade II-IV) or any patient with a known primary neoplasm of the CNS.
  • Medically indicated (diagnostic and/or therapeutic) tumor resection.
  • Informed consent from patient, age 18 or older to 75 years of age.
  • No racial or ethnic group or gender is excluded.

You may not qualify if:

  • Inability to provide informed consent prior to surgery.
  • Medical conditions that cannot be corrected prior to surgery that would be standard contraindications for neurosurgery.
  • Pregnant Women: Women of child-bearing age will be tested before surgery for pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Neurological Disorders and Stroke (NINDS)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Louis DN, Pomeroy SL, Cairncross JG. Focus on central nervous system neoplasia. Cancer Cell. 2002 Mar;1(2):125-8. doi: 10.1016/s1535-6108(02)00040-5. No abstract available.

    PMID: 12086870BACKGROUND
  • Maher EA, Furnari FB, Bachoo RM, Rowitch DH, Louis DN, Cavenee WK, DePinho RA. Malignant glioma: genetics and biology of a grave matter. Genes Dev. 2001 Jun 1;15(11):1311-33. doi: 10.1101/gad.891601. No abstract available.

    PMID: 11390353BACKGROUND
  • Asahara T, Murohara T, Sullivan A, Silver M, van der Zee R, Li T, Witzenbichler B, Schatteman G, Isner JM. Isolation of putative progenitor endothelial cells for angiogenesis. Science. 1997 Feb 14;275(5302):964-7. doi: 10.1126/science.275.5302.964.

    PMID: 9020076BACKGROUND

MeSH Terms

Conditions

GliomaBrain Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

August 8, 2003

First Posted

August 11, 2003

Study Start

August 1, 2003

Study Completion

October 1, 2004

Last Updated

March 4, 2008

Record last verified: 2004-10

Locations