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

Tracking Information

First Received Date ^ICMJE

February 2, 2001

Last Updated Date

February 14, 2009

Start Date ^ICMJE

March 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00010114 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

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.

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Condition ^ICMJE

Brain and Central Nervous System Tumors

Intervention ^ICMJE

Genetic: comparative genomic hybridization
Genetic: microarray analysis

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

up to 2 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00010114

Responsible Party

Study ID Numbers ^ICMJE

CDR0000068446, PBTC-N04

Study Sponsor ^ICMJE

Pediatric Brain Tumor Consortium

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Tobey MacDonald, MD

Children's Research Institute

Information Provided By

National Cancer Institute (NCI)

Verification Date

October 2002

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP