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CompletedNCT00010114Updated Jul 20, 2011

Genetic Study of Newly Diagnosed Central Nervous System Tumors in Young Children

An observational study in Central Nervous System Embryonal Neoplasm, sponsored by Pediatric Brain Tumor Consortium. Completed at 9 sites in United States. Open to participants aged Up to 2 Years. Per ClinicalTrials.gov, last updated 2011-07-20.

Sponsored by Pediatric Brain Tumor Consortium · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
83
Ages
Up to 2 Years
Sex
All
01

Study summary

RATIONALE: Genetic studies may help in understanding the genetic processes involved in the development of some types of cancer.

PURPOSE: Genetic study to learn more about genes involved in the development of central nervous system tumors in young children.

Read the detailed description

OBJECTIVES:

  • Identify known genes that have significantly different levels of expression, using microarray gene chip analysis, in infants with newly diagnosed metastatic vs non-metastatic embryonal central nervous system tumors.
  • Determine the protein expression of genes identified by microarray analysis that are involved in cellular functions that regulate angiogenesis, invasion, or metastasis in this patient population.
  • Determine the quantity of gene expression of the confirmed translationally expressed genes using semi-quantitative polymerase chain reaction.

OUTLINE: This is a multicenter study.

Tumor samples are analyzed using microarray gene chip analysis. Differentially expressed genes are evaluated for protein expression by standard immunohistochemistry and/or Western blot analysis, and gene expression is further quantified by semi-quantitative polymerase chain reaction.

PROJECTED ACCRUAL: Approximately 80-100 patients (20-25 with metastatic disease and 60-75 with non-metastatic disease) will be accrued for this study within 4-5 years.

02

Conditions studied

  • Central Nervous System Embryonal Neoplasm

Keywords

  • childhood central nervous system germ cell tumor
  • childhood choroid plexus tumor
  • untreated childhood supratentorial primitive neuroectodermal tumor
  • untreated childhood medulloblastoma
  • newly diagnosed childhood ependymoma
03

In context

Nervous System Neoplasms

538 studies on the registry are indexed under Nervous System Neoplasms; 14 are open to participants now.

This study's enrollment of 83 is close to the median of 87 across 50 observational studies indexed under Nervous System Neoplasms.

Browse Nervous System Neoplasms studies →

Lead sponsor

Pediatric Brain Tumor Consortium is the lead sponsor of 31 studies on the registry; none are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 2 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The participants in this study are infants (\< 3 years of age) with newly diagnosed medulloblastoma, primitive neuroectodermal tumor, or other embryonal tumor, atypical teratoid/rhabdoid tumor, intracranial germ cell tumor, or choroid plexus carcinoma who have received no prior therapy with the exception of steroids and have consented to allow research studies on banked tissue specimens

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed, newly diagnosed, primary intracranial embryonal central nervous system tumor

    • Medulloblastoma
    • Primitive neuroectodermal tumor
    • Medulloepithelioma
    • Ependymoblastoma
    • Neuroblastoma
    • Pineoblastoma
    • Atypical teratoid/rhabdoid tumor
    • Intracranial germ cell tumor
    • Choroid plexus carcinoma
    • M positive ependymoma
  • Potential enrollment on PBTC-001 therapeutic protocol

PATIENT CHARACTERISTICS:

Age:

  • Under 3

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • Prior steroids allowed

Radiotherapy:

  • No prior radiotherapy

Surgery:

  • Not specified

Other:

  • No concurrent investigational agents
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
83 participants (actual)

Groups and cohorts

  • Newly diagnosed embryonal tumors

    The participants in this study are infants (\< 3 years of age) with newly diagnosed medulloblastoma, primitive neuroectodermal tumor, or other embryonal tumor, atypical teratoid/rhabdoid tumor, intracranial germ cell tumor, or choroid plexus carcinoma who have received no prior therapy with the exception of steroids and have consented to allow research studies on banked tissue specimens

06

What researchers measure

Primary outcomes

  1. Genes that are expressed in metastatic vs. non-metastatic tumors

    Time frame: Prior to therapy

Secondary outcomes

  1. Protein expression of genes found to be expressed

    Time frame: Prior to therapy

07

Study locations

9 sites
  • UCSF Cancer Center and Cancer Research Institute
    San Francisco, California 94143-0128, United States
  • Children's National Medical Center
    Washington, District of Columbia 20010-2970, United States
  • Dana-Farber Cancer Institute
    Boston, Massachusetts 02115, United States
  • Duke Comprehensive Cancer Center
    Durham, North Carolina 27710, United States
  • Children's Hospital of Philadelphia
    Philadelphia, Pennsylvania 19104, United States
  • Children's Hospital of Pittsburgh
    Pittsburgh, Pennsylvania 15213, United States
  • Saint Jude Children's Research Hospital
    Memphis, Tennessee 38105-2794, United States
  • Baylor College of Medicine
    Houston, Texas 77030, United States
  • Children's Hospital and Regional Medical Center - Seattle
    Seattle, Washington 98105, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00010114
Lead sponsor
Pediatric Brain Tumor Consortium
Collaborators
National Cancer Institute (NCI)
First posted
Jun 6, 2003
Start date
Mar 2001
Primary completion
Mar 2003
Completion
Mar 2003
Last update
Jul 20, 2011

Study contacts

Tobey MacDonald, MD
study chair · Children's National Research Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.

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