Viewing Study NCT00010114



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Last Modification Date: 2024-10-26 @ 9:06 AM
Study NCT ID: NCT00010114
Status: COMPLETED
Last Update Posted: 2011-07-20
First Post: 2001-02-02

Brief Title: Genetic Study of Newly Diagnosed Central Nervous System Tumors in Young Children
Sponsor: Pediatric Brain Tumor Consortium
Organization: Pediatric Brain Tumor Consortium

Study Overview

Official Title: Gene Expression Profiling of Infant Embryonal Central Nervous System Tumors by Microarray Gene Chip Analysis Angiogenesis Invasion and Metastasis
Status: COMPLETED
Status Verified Date: 2011-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 andor 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
PBTC-N04 None None None