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NCT01498302 Clinical Trial

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

Leukemia Clinical Trial

Official title:
Interlaboratory Comparability Study of Residual Disease in Acute Myelogenous Leukemia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01498302
Other study ID # AAML12B5
Secondary ID COG-AAML12B5AAML
Status Completed
Phase N/A
First received December 22, 2011
Last updated July 7, 2016
Start date February 2012

Study information
Verified date July 2016
Source Children's Oncology Group
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender Both
Age group N/A to 120 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Other:
• diagnostic laboratory biomarker analysis

• flow cytometry

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Children's Oncology Group National Cancer Institute (NCI)

Outcome
Type Measure Description Time frame Safety issue
Primary Degree of concordance in the MRD assay results between laboratories No
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