NCT01498302

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 23, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Last Updated

July 11, 2016

Status Verified

July 1, 2016

Enrollment Period

4.4 years

First QC Date

December 22, 2011

Last Update Submit

July 7, 2016

Conditions

Leukemia

Keywords

childhood acute myeloid leukemia/other myeloid malignancies

Outcome Measures

Primary Outcomes (1)

  • Degree of concordance in the MRD assay results between laboratories

Interventions

diagnostic laboratory biomarker analysisOTHER
flow cytometryOTHER

Eligibility Criteria

AgeUp to 120 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Bone marrow and/or peripheral blood

MeSH Terms

Conditions

Leukemia

Interventions

Flow Cytometry

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Cell SeparationCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisCytophotometryFluorometryLuminescent MeasurementsPhotometryChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • J. Milburn Jessup, MD

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2011

First Posted

December 23, 2011

Study Start

February 1, 2012

Primary Completion

July 1, 2016

Last Updated

July 11, 2016

Record last verified: 2016-07