Comparison of Laboratory Test Results of Minimal-Residual Disease in Samples From Patients With Acute Myeloid Leukemia

Interlaboratory Comparability Study of Residual Disease in Acute Myelogenous Leukemia

RATIONALE: Diagnostic procedures that find residual disease may help predict if the disease will come back in patients diagnosed with acute myeloid leukemia.

PURPOSE: This research trial studies the comparison of laboratory test results for minimal residual disease in samples from patients with acute myeloid leukemia.

Study Overview

• Status: Completed
• Conditions: Leukemia
• Intervention / Treatment: Other: diagnostic laboratory biomarker analysis; Other: flow cytometry

Detailed Description

OBJECTIVES:

• To promote harmonization between Cooperative Group Reference Laboratories conducting minimal-residual disease (MRD) evaluation of acute myeloid leukemia by flow cytometry.

OUTLINE: Archived bone marrow and blood samples, distributed to the Eastern Cooperative Oncology Group, Southwest Oncology Group, and Cancer and Leukemia Group B laboratories, are analyzed for leukemia-associated immunophenotype (LAIP) assays and minimal residual disease studies by flow cytometry. Results are then provided to the National Cancer Institute for assessment and comparability of test results.

• Study Type: Observational
• Enrollment (Anticipated): 10

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 120 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Acute myeloid leukemia (AML) enrolled on Children's Oncology Group (COG) studies.

Description

DISEASE CHARACTERISTICS:

• Non-identified cryopreserved samples of bone marrow and/or peripheral blood from patients with acute myeloid leukemia (AML) from the Children Oncology Group (COG) studies

  • Baseline/diagnostic AML samples
  • Samples collected after initial treatment and representing varying levels of residual blast counts

PATIENT CHARACTERISTICS:

• Not specified

PRIOR CONCURRENT THERAPY:

• Not specified

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Degree of concordance in the MRD assay results between laboratories

Collaborators and Investigators

• Sponsor: Children's Oncology Group
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: J. Milburn Jessup, MD, National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (ACTUAL): July 1, 2016

Study Registration Dates

• First Submitted: December 22, 2011
• First Submitted That Met QC Criteria: December 22, 2011
• First Posted (ESTIMATE): December 23, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): July 11, 2016
• Last Update Submitted That Met QC Criteria: July 7, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: childhood acute myeloid leukemia/other myeloid malignancies
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Leukemia
• Other Study ID Numbers: AAML12B5 (OTHER: Children's Oncology Group); COG-AAML12B5 (OTHER: Children's Oncology Group); NCI-2012-00098 (REGISTRY: CTRP (Clinical Trial Reporting Program))