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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01498302
Recruitment Status : Completed
First Posted : December 23, 2011
Last Update Posted : July 11, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Brief Summary:

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.

Condition or disease Intervention/treatment
Leukemia Other: diagnostic laboratory biomarker analysis Other: flow cytometry

Detailed Description:


  • 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.

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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Interlaboratory Comparability Study of Residual Disease in Acute Myelogenous Leukemia
Study Start Date : February 2012
Actual Primary Completion Date : July 2016

Primary Outcome Measures :
  1. Degree of concordance in the MRD assay results between laboratories

Biospecimen Retention:   Samples With DNA
Bone marrow and/or peripheral blood

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 120 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Acute myeloid leukemia (AML) enrolled on Children's Oncology Group (COG) studies.


  • 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


  • Not specified


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01498302

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

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Responsible Party: Children's Oncology Group Identifier: NCT01498302    
Other Study ID Numbers: AAML12B5
COG-AAML12B5 ( Other Identifier: Children's Oncology Group )
AAML12B5 ( Other Identifier: Children's Oncology Group )
NCI-2012-00098 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: December 23, 2011    Key Record Dates
Last Update Posted: July 11, 2016
Last Verified: July 2016
Keywords provided by Children's Oncology Group:
childhood acute myeloid leukemia/other myeloid malignancies
Additional relevant MeSH terms:
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Neoplasms by Histologic Type