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NCT01507441 Clinical Trial

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

Leukemia Clinical Trial

Official title:
Whole Exon Sequencing of Down Syndrome Acute Myeloid Leukemia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01507441
Other study ID # AAML12B4
Secondary ID COG-AAML12B4AAML
Status Completed
Phase N/A
First received January 6, 2012
Last updated May 17, 2016
Start date February 2012

Study information
Verified date May 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: 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender Both
Age group N/A to 3 Years
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Genetic:
• gene mapping

• microarray analysis

• mutation analysis

• nucleic acid sequencing

Other:
• laboratory biomarker analysis

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 Identification of unique mutations through whole-genome sequencing No
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