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| Sponsor: | Children's Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00482352 |
Purpose
RATIONALE: Developing a risk-group classification guide may help doctors assign patients with newly diagnosed acute lymphoblastic leukemia to treatment clinical trials.
PURPOSE: This clinical trial is studying risk-group classification of patients with newly diagnosed acute lymphoblastic leukemia.
| Condition | Intervention |
|---|---|
|
Leukemia |
Genetic: DNA ploidy analysis Genetic: chromosomal translocation analysis Genetic: fluorescence in situ hybridization Genetic: polymorphism analysis Other: immunologic technique Other: laboratory biomarker analysis Procedure: biopsy |
| Study Type: | Observational |
| Official Title: | Classification Of Acute Lymphoblastic Leukemia |
| Estimated Enrollment: | 10500 |
| Study Start Date: | January 2004 |
| Estimated Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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 patient's assignment to specific treatment clinical trials (consistent with acute lymphoblastic leukemia).
After completion of induction therapy, patients are followed once or twice annually.
Eligibility| Ages Eligible for Study: | 1 Year to 30 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Newly diagnosed acute lymphoblastic leukemia, defined by any of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Contacts and Locations
Show 204 Study Locations| Study Chair: | Mignon Loh, MD | University of California, San Francisco |
More Information
| Study ID Numbers: | CDR0000344369, COG-AALL03B1 |
| Study First Received: | June 4, 2007 |
| Last Updated: | February 6, 2010 |
| ClinicalTrials.gov Identifier: | NCT00482352 History of Changes |
| Health Authority: | Unspecified |
|
untreated adult acute lymphoblastic leukemia untreated childhood acute lymphoblastic leukemia |
|
Lymphatic Diseases Leukemia Neoplasms Leukemia, Lymphoid Immunoproliferative Disorders |
Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma Immune System Diseases Lymphoproliferative Disorders |