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OpenTrials
Completed

NCT Number: NCT00010114

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

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.

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Key information

Age range

Up to 2 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UCSF Cancer Center and Cancer Research Institute, San Francisco, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Sponsors and collaborators

Lead sponsor

Pediatric Brain Tumor Consortium

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Gene Expression Profiling of Infant Embryonal Central Nervous System Tumors by Microarray Gene Chip Analysis: Angiogenesis, Invasion and Metastasis

Important dates

Study start
2001
Primary completion
2003
Study completion
2003
First posted
Jun 6, 2003
Registry last updated
Jul 20, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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