Clinical Trials Directory

Trials / Completed

CompletedNCT00003096

Gene Testing to Help in the Diagnosis and Treatment of Childhood Brain Tumors

Molecular Biology of Pediatric Brain Tumors

Status
Completed
Phase
Study type
Observational
Enrollment
88 (actual)
Sponsor
Children's Oncology Group · Network
Sex
All
Age
20 Years
Healthy volunteers
Not accepted

Summary

RATIONALE: Analyzing the number and structure of genes found in a child's cancer cells may help doctors improve methods of diagnosing and treating children with brain tumors. PURPOSE: This clinical trial is studying the number and structure of genes in cancer cells of children with brain tumors.

Detailed description

OBJECTIVES: * Determine the chromosomal gains and losses by DNA ploidy analysis and comparative genomic hybridization in patients with primitive neuroectodermal tumors or medulloblastomas. * Determine the frequency of specific chromosomal abnormalities, including deletions of chromosomal regions 6, 17, and 22, in these patients. * Perform a statistical analysis to determine possible associations of chromosomal abnormalities and DNA ploidy with patient age, tumor histology, tumor location, extent of disease, and event-free survival. OUTLINE: DNA ploidy analysis will be performed to determine the overall level of aneuploidy. The results are compared to the comparative genomic hybridization (CGH) analysis, which is used to demonstrate tumor-specific losses or gains, including amplification, of specific chromosomal regions. Tumors are also screened for specific abnormalities by fluorescent in situ hybridization (FISH), which detects chromosomal rearrangements, including balanced translocations, deletions, amplifications, etc. PCR-based microsatellite polymorphism analysis may also be performed. Primitive neuroectodermal tumors (PNETs) are screened by FISH with a distal 17p13.3 cosmid and a 17q25 cosmid to identify tumors with a 17p deletion. Atypical teratoid/rhabdoid tumors and PNETs without a 17p deletion are screened by FISH with a series of cosmids from 22q11.2. PNETs are also screened by interphase FISH with cosmids from chromosome 6 to identify tumors with deletions. Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment. PROJECTED ACCRUAL: This study will accrue 360 specimens.

Conditions

Interventions

TypeNameDescription
GENETICDNA ploidy analysis
GENETICcomparative genomic hybridization
GENETICcytogenetic analysis
GENETICfluorescence in situ hybridization

Timeline

Start date
1996-12-01
Primary completion
2006-03-01
Completion
2007-03-01
First posted
2003-01-27
Last updated
2014-08-06

Locations

61 sites across 3 countries: United States, Australia, Canada

Source: ClinicalTrials.gov record NCT00003096. Inclusion in this directory is not an endorsement.