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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01507441
First received: January 6, 2012
Last updated: February 14, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention
Leukemia
 Genetic: gene mapping
Genetic: microarray analysis
Genetic: mutation analysis
Genetic: nucleic acid sequencing
Other: laboratory biomarker analysis

Study Type: Observational
Official Title: Whole Exon Sequencing of Down Syndrome Acute Myeloid Leukemia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Identification of unique mutations through whole-genome sequencing [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: February 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   up to 3 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01507441

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Jeffrey Taub, MD Children's Hospital of Michigan
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Peter C. Adamson, Children's Oncology Group - Group Chair Office
ClinicalTrials.gov Identifier: NCT01507441     History of Changes
Other Study ID Numbers: CDR0000721624, COG-AAML12B4
Study First Received: January 6, 2012
Last Updated: February 14, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
childhood myelodysplastic syndromes
childhood acute myeloid leukemia/other myeloid malignancies
childhood acute megakaryocytic leukemia (M7)

Additional relevant MeSH terms:
Down Syndrome
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Mental Retardation
Neurobehavioral Manifestations
Neurologic Manifestations
 Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on May 19, 2013