Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00010101
Status:
TERMINATED
Last Update Posted:
2011-07-20
First Post:
2001-02-02
Brief Title:
Genetic Study of Brain Tumors in Young Children
Sponsor:
Pediatric Brain Tumor Consortium
Organization:
Pediatric Brain Tumor Consortium
Study Overview
Official Title:
INI1 Mutation Analysis and Expression Profiling of Embryonal CNS Tumors
Status:
TERMINATED
Status Verified Date:
2011-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor accrual
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 understand how genes may be involved in the development of brain tumors in young children
PURPOSE Genetic study to understand how genes may be involved in the development of brain tumors in young children
Detailed Description:
OBJECTIVES
Determine the frequency and type of deletions and mutations of the INI1 gene in infants with embryonal central nervous system tumors
Compare the gene expression profiles in infants with atypical teratoidrhabdoid tumors vs medulloblastoma or primitive neuroectodermal tumor
OUTLINE This is a multicenter study
Tumor samples are analyzed by fluorescence in situ hybridization FISH for deletions of INI1 gene in chromosome band 22q112 Tumors without demonstration of deletions of INI1 gene by FISH are examined by polymerase chain reaction PCR-based microsatellite analysis for loss of heterozygosity using markers that map to 22q112
DNA from tumor tissue is analyzed for mutations in the exons of the INI1 gene Isolated matched normal DNA may be analyzed for identification of germline mutations Parental DNA may be analyzed to identify inherited germline mutations of the INI1 gene
The patients physician may receive the results of the genetic testing The results do not influence the type or duration of treatment
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study within 25 months
Determine the frequency and type of deletions and mutations of the INI1 gene in infants with embryonal central nervous system tumors
Compare the gene expression profiles in infants with atypical teratoidrhabdoid tumors vs medulloblastoma or primitive neuroectodermal tumor
OUTLINE This is a multicenter study
Tumor samples are analyzed by fluorescence in situ hybridization FISH for deletions of INI1 gene in chromosome band 22q112 Tumors without demonstration of deletions of INI1 gene by FISH are examined by polymerase chain reaction PCR-based microsatellite analysis for loss of heterozygosity using markers that map to 22q112
DNA from tumor tissue is analyzed for mutations in the exons of the INI1 gene Isolated matched normal DNA may be analyzed for identification of germline mutations Parental DNA may be analyzed to identify inherited germline mutations of the INI1 gene
The patients physician may receive the results of the genetic testing The results do not influence the type or duration of treatment
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study within 25 months
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-N03 | None | None | None |