Risk-Group Classification of Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
- Conditions
- Untreated Childhood Acute Lymphoblastic LeukemiaUntreated Adult Acute Lymphoblastic Leukemia
- Registration Number
- NCT00482352
- Lead Sponsor
- Children's Oncology Group
- 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 Children's 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 11196
-
Newly diagnosed acute lymphoblastic leukemia, defined by any of the following:
- At least 25% blasts in the bone marrow
- Absolute blast count at least 10,000/mm^3, if bone marrow aspiration is not performed
-
No prior registration on this study
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Development of a classification guide to help determine patient assignment to a specific treatment clinical trial for newly diagnosed acute lymphoblastic leukemia (ALL) Up to 5 years Development of a classification database for correlative studies Up to 5 years Development of a central reference guide for all required and research only ALL studies Up to 5 years Development of a leukemia and germline specimen bank for current and future research Up to 5 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (200)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
University of South Alabama
🇺🇸Mobile, Alabama, United States
Phoenix Childrens Hospital
🇺🇸Phoenix, Arizona, United States
University of Arizona Health Sciences Center
🇺🇸Tucson, Arizona, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Southern California Permanente Medical Group
🇺🇸Downey, California, United States
City of Hope Medical Center
🇺🇸Duarte, California, United States
Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
Miller Children's Hospital
🇺🇸Long Beach, California, United States
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Scroll for more (190 remaining)University of Alabama at Birmingham🇺🇸Birmingham, Alabama, United States