Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00028509
Status:
COMPLETED
Last Update Posted:
2014-02-13
First Post:
2002-01-04
Brief Title:
Brain Function in Children Previously Treated on Clinical Trials POG-9605 and POG-9201
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
Assessment of Clinical and Neuroradiologic Evidence of Methotrexate Leukoencephalopathy in Children Treated on POG 9605 and 9201
Status:
COMPLETED
Status Verified Date:
2014-02
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 Assessing the effects of methotrexate on brain function in children may improve the ability to plan treatment and decrease side effects
PURPOSE Clinical trial to compare brain function of children who have been previously treated with methotrexate
PURPOSE Clinical trial to compare brain function of children who have been previously treated with methotrexate
Detailed Description:
OBJECTIVES
Compare the incidence of neuropsychological abnormalities and leukoencephalopathy in children previously treated with methotrexate on protocols POG-9605 versus POG-9201
OUTLINE This is a multicenter study
More than 3 years after completion of therapy patients undergo 9 different tests to assess intelligence memory learning attention concentration processing of information functioning and visual-motor integration Patients also undergo MRI of the head
PROJECTED ACCRUAL A total of 30-54 patients previously treated on protocol POG-9201 will be accrued for this study A total of 60-108 patients previously treated on protocol POG-9605 will be accrued for this study
Compare the incidence of neuropsychological abnormalities and leukoencephalopathy in children previously treated with methotrexate on protocols POG-9605 versus POG-9201
OUTLINE This is a multicenter study
More than 3 years after completion of therapy patients undergo 9 different tests to assess intelligence memory learning attention concentration processing of information functioning and visual-motor integration Patients also undergo MRI of the head
PROJECTED ACCRUAL A total of 30-54 patients previously treated on protocol POG-9201 will be accrued for this study A total of 60-108 patients previously treated on protocol POG-9605 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 |
|---|---|---|---|
| CDR0000069100 | OTHER | Clinical Trialsgov | None |
| COG-ACCL0131 | OTHER | None | None |
| NCI-P01-0198 | None | None | None |