Risk-Based Classification System of Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 9835
Summary
- Conditions
- Acute Lymphoblastic Leukemia
- Type
- Observational
- Design
- Observational Model: Case-OnlyTime Perspective: Prospective
Participation Requirements
- Age
- Younger than 30 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. To provide a risk classification scheme for all patients with newly diagnosed acute lymphoblastic leukemia (ALL), which will be used to assign treatment on Children?s Oncology Group (COG) frontline ALL treatment studies. II. To capture classification data for correlative studi...
PRIMARY OBJECTIVES: I. To provide a risk classification scheme for all patients with newly diagnosed acute lymphoblastic leukemia (ALL), which will be used to assign treatment on Children?s Oncology Group (COG) frontline ALL treatment studies. II. To capture classification data for correlative studies accompanying current COG ALL treatment protocols. III. To provide a central reference guide for all required and research studies that will be conducted in local and reference laboratories for all newly diagnosed ALL patients. IV. To provide a mechanism for optional banking of leukemia and germline specimens for current and future research. OUTLINE: Patients undergo blood sample collection and bone marrow biopsies at baseline and during and after induction therapy for immunophenotyping for ALL confirmation and classification, deoxyribonucleic acid (DNA) ploidy, genomic variation, and cytogenetic (BCR-ABL, trisomies 4+10, and molecular testing for translocations) analysis by flow cytometry and fluorescent in situ hybridization (FISH). Immunophenotype results obtained on this study are used to determine patient's assignment to specific clinical-trial treatments. Some samples (leukemic and germline) may be banked for current and/or future analyses.
Tracking Information
- NCT #
- NCT01142427
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Karen R Rabin Children's Oncology Group