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Tracking Information | |||||
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First Received Date † | June 4, 2007 | ||||
Last Updated Date | May 12, 2009 | ||||
Start Date † | January 2004 | ||||
Current Primary Outcome Measures † |
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Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00482352 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † | |||||
Original Secondary Outcome Measures † | |||||
Descriptive Information | |||||
Brief Title † | Risk-Group Classification of Patients With Newly Diagnosed Acute Lymphoblastic Leukemia | ||||
Official Title † | Classification Of Acute Lymphoblastic Leukemia | ||||
Brief Summary | 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. |
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Detailed Description | 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. |
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Study Phase | |||||
Study Type † | Observational | ||||
Study Design † | |||||
Condition † | Leukemia | ||||
Intervention † |
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Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Recruiting | ||||
Estimated Enrollment † | 10500 | ||||
Completion Date | |||||
Estimated Primary Completion Date | December 2007 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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Gender | Both | ||||
Ages | 1 Year to 30 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States, Australia, Canada, New Zealand, Switzerland | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00482352 | ||||
Responsible Party | |||||
Secondary IDs †† | COG-AALL03B1 | ||||
Study Sponsor † | Children's Oncology Group | ||||
Collaborators †† | National Cancer Institute (NCI) | ||||
Investigators † |
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Information Provided By | National Cancer Institute (NCI) | ||||
Verification Date | May 2009 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |