DNA Analysis of Bone Marrow and Blood Samples From Young Patients With Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia

Completed

• Conditions: Leukemia
• Interventions: Genetic: Southern blotting; Genetic: chromosomal translocation analysis; Genetic: cytogenetic analysis; Genetic: gene rearrangement analysis; Genetic: mutation analysis

• Registration Number: NCT00899652
• Lead Sponsor: Children's Oncology Group

Brief Summary

RATIONALE: Studying samples of bone marrow and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This laboratory study is looking at DNA in bone marrow and blood samples from young patients with acute myeloid leukemia or acute lymphoblastic leukemia.

Detailed Description

OBJECTIVES:

* Characterize the clinical, morphologic, immunologic, cytogenetic, and molecular heterogeneity of acute lymphoblastic leukemia or acute myeloid leukemia (AML) in infants and monoblastic variants of AML in young patients.

* Characterize the clinical, morphologic, immunologic, cytogenetic, and molecular heterogeneity of secondary AML in young patients.

* Compare secondary AML vs de novo AML at the level of Southern blot, breakpoint sequence, and DNA topoisomerase II cleavage sites.

OUTLINE: This is a multicenter study.

Bone marrow or blood are collected and analyzed by Southern blot for chromosome 11q23 breakpoints and translocations. Samples from patients with secondary acute myeloid leukemia are also examined for MLL gene rearrangements.

PROJECTED ACCRUAL: A total of 250 patients will be accrued for this study.

Study Timeline

• Study Start: 1997-01
• Primary Completion: 2005-09
• Study Completion: 2006-09
• Study First Submitted: 2009-05-09
• Study First Submitted QC: 2009-05-09
• Study First Posted: 2009-05-12
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-24
• Last Update Posted: 2017-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 149

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All Patients	chromosomal translocation analysis	Completion of Telephone Study Entry Form, Additional On Study Form, and Specimen Transmittal Form.
All Patients	mutation analysis	Completion of Telephone Study Entry Form, Additional On Study Form, and Specimen Transmittal Form.
All Patients	Southern blotting	Completion of Telephone Study Entry Form, Additional On Study Form, and Specimen Transmittal Form.
All Patients	cytogenetic analysis	Completion of Telephone Study Entry Form, Additional On Study Form, and Specimen Transmittal Form.
All Patients	gene rearrangement analysis	Completion of Telephone Study Entry Form, Additional On Study Form, and Specimen Transmittal Form.

Primary Outcome Measures

Name	Time	Method
Clinical, morphologic, immunologic, cytogenetic, and molecular characteristics of acute lymphoblastic leukemia and de novo and secondary acute myeloid leukemia (AML)
Comparison of secondary AML vs de novo AML at the level of Southern blot, breakpoint sequence, and DNA topoisomerase II cleavage sites