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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01498302
First Posted: December 23, 2011
Last Update Posted: July 11, 2016
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
  Purpose

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 Intervention
Leukemia Other: diagnostic laboratory biomarker analysis Other: flow cytometry

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Interlaboratory Comparability Study of Residual Disease in Acute Myelogenous Leukemia

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

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

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

Estimated Enrollment: 10
Study Start Date: February 2012
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 120 Years   (Child, Adult, Senior)
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.
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01498302


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

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01498302     History of Changes
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 Submitted: December 22, 2011
First Posted: December 23, 2011
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:
Leukemia
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid