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Risk-Based Classification System of Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

2014-08-27 03:12:57 | BioPortfolio

Summary

RATIONALE: Gathering health information about patients with acute lymphoblastic leukemia may help doctors learn more about the disease and plan the best treatment.

PURPOSE: This research study is developing a risk-based classification system for patients with newly diagnosed acute lymphoblastic leukemia.

Description

OBJECTIVES:

- To provide a risk-based classification system based on clinical, pathological, molecular, and early response data that will be used to assign all patients with newly diagnosed acute lymphoblastic leukemia (ALL) to the Children's Oncology Group (GOG) frontline specific-treatment studies.

- To capture classification data for correlative studies accompanying current COG ALL treatment protocols.

- 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.

- To provide a mechanism for optional banking of leukemia and germline specimens for current and future research.

OUTLINE: This is a multicenter study. Patients are stratified according to diagnosis (B-cell precursor vs infant vs T-cell ALL).

Patients undergo blood sample collection and bone marrow biopsies at baseline and during and after induction therapy for immunophenotyping for ALL confirmation and classification, DNA ploidy, genomic variation, and cytogenetic (BCR-ABL, trisomies 4+10, and molecular testing for translocations) analysis by flow cytometry and fluorescence 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.

Study Design

N/A

Conditions

Leukemia

Intervention

DNA ploidy analysis, chromosomal translocation analysis, cytogenetic analysis, fluorescence in situ hybridization, flow cytometry, laboratory biomarker analysis

Status

Not yet recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:57-0400

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