Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003933
Status:
COMPLETED
Last Update Posted:
2014-08-07
First Post:
1999-11-01
Brief Title:
Diagnostic Study of Gene Alterations in Children Who Have Been Treated for Relapsed Acute Lymphocytic Leukemia
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
The Incidence and Prognostic Significance of P16 INK4A P15 INK4B Gene Alterations in Children With Relapsed ALL Treated on CCG-1941
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 Diagnostic procedures such as genetic testing may improve the ability to detect acute lymphocytic leukemia and determine the extent of disease
PURPOSE Diagnostic study to try to detect changes in the genes of children who have been treated for relapsed acute lymphocytic leukemia
PURPOSE Diagnostic study to try to detect changes in the genes of children who have been treated for relapsed acute lymphocytic leukemia
Detailed Description:
OBJECTIVES
Determine the incidence of p16p15 homozygous deletions and p15 promoter hypermethylation in acute lymphocytic leukemia cells of children treated on protocol CCG-1941
Determine the prognostic importance of p16p15 abnormalities in these children
Determine the presence or absence of p16p15 abnormalities in the dominant clone at diagnosis if present at relapse in these patients
OUTLINE Frozen cells are obtained from samples collected on protocol CCG-1941 DNA is isolated and examined using Southern blot analysis to assay for deletions and promoter hypermethylation of p16 andor p15
PROJECTED ACCRUAL Approximately 100 samples will be obtained for this study
Determine the incidence of p16p15 homozygous deletions and p15 promoter hypermethylation in acute lymphocytic leukemia cells of children treated on protocol CCG-1941
Determine the prognostic importance of p16p15 abnormalities in these children
Determine the presence or absence of p16p15 abnormalities in the dominant clone at diagnosis if present at relapse in these patients
OUTLINE Frozen cells are obtained from samples collected on protocol CCG-1941 DNA is isolated and examined using Southern blot analysis to assay for deletions and promoter hypermethylation of p16 andor p15
PROJECTED ACCRUAL Approximately 100 samples will be obtained for this study
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 |
|---|---|---|---|
| COG-B9805 | OTHER | None | None |
| CCG-B9805 | OTHER | None | None |
| CDR0000067125 | OTHER | Clinical Trialsgov | None |