NCT01507441

Brief Summary

RATIONALE: Studying samples of blood, tissue, and bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research trial studies DNA samples from patients with Down syndrome and acute myeloid leukemia treated on COG-AAML0431 clinical trial.

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 10, 2012

Completed
22 days until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Last Updated

May 18, 2016

Status Verified

May 1, 2016

Enrollment Period

4.2 years

First QC Date

January 6, 2012

Last Update Submit

May 17, 2016

Conditions

Leukemia

Keywords

childhood myelodysplastic syndromeschildhood acute myeloid leukemia/other myeloid malignancieschildhood acute megakaryocytic leukemia (M7)

Outcome Measures

Primary Outcomes (1)

  • Identification of unique mutations through whole-genome sequencing

Interventions

gene mappingGENETIC
microarray analysisGENETIC
mutation analysisGENETIC
nucleic acid sequencingGENETIC
laboratory biomarker analysisOTHER

Eligibility Criteria

AgeUp to 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Down syndrome children diagnosed with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS).

DISEASE CHARACTERISTICS: * Down syndrome children diagnosed with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) * Clinical samples from patients enrolled on the Children's Oncology Group (COG) AAML0431 phase III clinical trial, and from the Children's Hospital of Michigan Cell Bank * Diagnostic blast samples and matched remission samples 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

MeSH Terms

Conditions

Leukemia

Interventions

Chromosome MappingMicroarray AnalysisBase Sequence

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Genetic TechniquesInvestigative TechniquesMicrochip Analytical ProceduresMolecular StructureBiochemical PhenomenaChemical PhenomenaGenetic StructuresGenetic Phenomena

Study Officials

  • Jeffrey Taub, MD

    Children's Hospital of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 6, 2012

First Posted

January 10, 2012

Study Start

February 1, 2012

Primary Completion

May 1, 2016

Last Updated

May 18, 2016

Record last verified: 2016-05