Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003096
Status:
COMPLETED
Last Update Posted:
2014-08-06
First Post:
1999-11-01
Brief Title:
Gene Testing to Help in the Diagnosis and Treatment of Childhood Brain Tumors
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
Molecular Biology of Pediatric Brain Tumors
Status:
COMPLETED
Status Verified Date:
2014-08
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 Analyzing the number and structure of genes found in a childs 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
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 17p133 cosmid and a 17q25 cosmid to identify tumors with a 17p deletion Atypical teratoidrhabdoid tumors and PNETs without a 17p deletion are screened by FISH with a series of cosmids from 22q112 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
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 17p133 cosmid and a 17q25 cosmid to identify tumors with a 17p deletion Atypical teratoidrhabdoid tumors and PNETs without a 17p deletion are screened by FISH with a series of cosmids from 22q112 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
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 |
|---|---|---|---|
| CDR0000065814 | OTHER | Clinical Trialsgov | None |
| COG-B971 | OTHER | None | None |
| CCG-B971 | OTHER | None | None |