Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00482352
Status:
COMPLETED
Last Update Posted:
2023-08-03
First Post:
2007-06-04
Brief Title:
Risk-Group Classification of Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
Classification Of Acute Lymphoblastic Leukemia
Status:
COMPLETED
Status Verified Date:
2023-08
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:
This clinical trial is studying risk-group classification of patients with newly diagnosed acute lymphoblastic leukemia Developing a risk-group classification guide may help doctors assign patients with newly diagnosed acute lymphoblastic leukemia to treatment clinical trials
Detailed Description:
OBJECTIVES
I Provide a classification guide that will organize the clinical and laboratory data necessary for assigning each patient with newly diagnosed acute lymphoblastic leukemia ALL to a specific treatment clinical trial
II Provide an administrative base to capture classification data for correlative studies accompanying current Childrens Oncology Group COG ALL treatment clinical trials
III Provide a central reference guide for all required and research only ALL studies that will be conducted at local and reference laboratories
IV Provide a mechanism for optional banking of leukemia and germline specimens for current and future research
OUTLINE
Patients undergo blood collection and bone marrow biopsies at baseline and at the end of induction therapy for immunophenotyping for marker identification molecular testing for translocations trisomy analysis by fluorescence in situ hybridization FISH and DNA ploidy Immunophenotype results obtained on this study are used to determine the patients assignment to specific treatment clinical trials consistent with acute lymphoblastic leukemia
After completion of induction therapy patients are followed once or twice annually
I Provide a classification guide that will organize the clinical and laboratory data necessary for assigning each patient with newly diagnosed acute lymphoblastic leukemia ALL to a specific treatment clinical trial
II Provide an administrative base to capture classification data for correlative studies accompanying current Childrens Oncology Group COG ALL treatment clinical trials
III Provide a central reference guide for all required and research only ALL studies that will be conducted at local and reference laboratories
IV Provide a mechanism for optional banking of leukemia and germline specimens for current and future research
OUTLINE
Patients undergo blood collection and bone marrow biopsies at baseline and at the end of induction therapy for immunophenotyping for marker identification molecular testing for translocations trisomy analysis by fluorescence in situ hybridization FISH and DNA ploidy Immunophenotype results obtained on this study are used to determine the patients assignment to specific treatment clinical trials consistent with acute lymphoblastic leukemia
After completion of induction therapy patients are followed once or twice annually
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 |
|---|---|---|---|
| NCI-2009-00303 | REGISTRY | None | None |
| COG-AALL03B1 | OTHER | None | None |
| CDR0000344369 | OTHER | None | None |
| AALL03B1 | OTHER | None | None |
| AALL03B1 | OTHER | None | None |
| U10CA098543 | NIH | CTEP | httpsreporternihgovquickSearchU10CA098543 |