Studying DNA in Samples From Younger Patients With Down Syndrome and Acute Myeloid Leukemia Treated on COG-AAML0431 Clinical Trial

NCT01507441 — Completed, 10 participants, Children's Oncology Group

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Whole Exon Sequencing of Down Syndrome Acute Myeloid Leukemia

Registry	NCT01507441
Status	Completed
Study type	Observational
Enrollment	10 (Estimated)
Sponsor	Children's Oncology Group (Network); collaborators: National Cancer Institute (NCI)
Conditions	Leukemia
Interventions	gene mapping, microarray analysis, mutation analysis, nucleic acid sequencing, laboratory biomarker analysis (Genetic, other)
Dates	start 2012-02-01, primary completion 2016-05-01, first posted 2012-01-10, last updated 2016-05-18

-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.

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+Detailed description

OBJECTIVES:

* To identify new genetic abnormalities associated with acute myeloid leukemia (AML) in patients with Down syndrome through whole-genome sequencing.

OUTLINE: This is a multicenter study.

Extracted DNA and RNA from cryopreserved specimens are analyzed for genomic sequencing, gene mutation, and microarray analysis.

+Arms and interventions

gene mapping (Genetic)
microarray analysis (Genetic)
mutation analysis (Genetic)
nucleic acid sequencing (Genetic)
laboratory biomarker analysis (Other)

+Outcome measures

Primary outcomes

Identification of unique mutations through whole-genome sequencing

+Eligibility

Sex: All, ages: any to 3 Years

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

+Investigators

Jeffrey Taub, MD, Principal investigator, Children's Hospital of Michigan