Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003291
Status:
COMPLETED
Last Update Posted:
2014-08-08
First Post:
1999-11-01
Brief Title:
Molecular Genetic Lesions and Clinical Outcomes in Children With Acute Lymphoblastic Leukemia
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
Molecular Genetic Lesions and Clinical Outcome in Pediatric ALL Patients
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 The identification of gene mutations may allow doctors to better determine the prognosis of children with acute lymphoblastic leukemia
PURPOSE This clinical trial is studying gene mutations to see if they are related to prognosis of cancer in children with acute lymphoblastic leukemia
PURPOSE This clinical trial is studying gene mutations to see if they are related to prognosis of cancer in children with acute lymphoblastic leukemia
Detailed Description:
OBJECTIVES
Examine the prognostic significance of deletion of the p16 MTS1 CDKN21 gene in children with acute lymphoblastic leukemia
Attempt to correlate the incidence of specific nonrandom combinations of molecular genetic lesions with clinical outcome in these patients
OUTLINE Patients are stratified by risk standard vs high
Bone marrow specimens from patients enrolled in CCG-1922 CCG-1882 or CCG-1901 are analyzed for the following genetic lesions p16 deletion p14 deletion and p15 deletion
Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment
Patients are followed for at least 3 years
PROJECTED ACCRUAL A total of 200 patients will be accrued for this study
Examine the prognostic significance of deletion of the p16 MTS1 CDKN21 gene in children with acute lymphoblastic leukemia
Attempt to correlate the incidence of specific nonrandom combinations of molecular genetic lesions with clinical outcome in these patients
OUTLINE Patients are stratified by risk standard vs high
Bone marrow specimens from patients enrolled in CCG-1922 CCG-1882 or CCG-1901 are analyzed for the following genetic lesions p16 deletion p14 deletion and p15 deletion
Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment
Patients are followed for at least 3 years
PROJECTED ACCRUAL A total of 200 patients will be accrued 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-B969 | OTHER | None | None |
| CCG-B969 | OTHER | None | None |
| CDR0000066224 | OTHER | Clinical Trialsgov | None |