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Studying Biomarker Expression in Samples From Patients With Down Syndrome and Acute Myeloid Leukemia or Other Transient Myeloproliferative Disorder

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group Identifier:
First received: January 13, 2012
Last updated: May 13, 2016
Last verified: May 2016

RATIONALE: Studying samples of blood, tissue, and bone marrow from patients with cancer in the laboratory may help doctors learn about changes that occur in RNA and identify biomarkers related to cancer.

PURPOSE: This research trial studies RNA samples from patients with Down syndrome and acute myeloid leukemia or other transient myeloproliferative disorder.

Condition Intervention
Leukemia Genetic: RNA analysis Genetic: reverse transcriptase-polymerase chain reaction Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Analysis of MicroRNA Expression in Down Syndrome Acute Myeloid Leukemia and the Transient Myeloproliferative Disorder

Resource links provided by NLM:

Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Gene expression levels between DS AMKL and non-DS AMKL patients

Enrollment: 60
Study Start Date: February 2012
Study Completion Date: May 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Detailed Description:


  • To compare miRNA expression in distinctive diagnostic groups: transient myeloproliferative disorder (TMD), Down syndrome (DS) acute megakaryocytic leukemia (AMkL), non-DS AMkL, and in remission DS samples (representing germline, non-malignant samples).

OUTLINE: Archived RNA samples are analyzed for mature micro (mi)RNA expression by real-time RT-PCR. Results are then compared with miRNA expression of non-Down syndrome patients with acute megakaryocytic leukemia.


Ages Eligible for Study:   up to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Down syndrome (DS) diagnosed with acute myeloid leukemia or transient myeloproliferative disorder.


  • Patients with Down syndrome (DS) diagnosed with acute myeloid leukemia or transient myeloproliferative disorder
  • Clinical samples obtained from patients enrolled on the COG AAML0431 and COG AAML08B1


  • Previously consented to biologic studies


  • See Disease Characteristics
  Contacts and Locations
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Please refer to this study by its identifier: NCT01511575

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

Responsible Party: Children's Oncology Group Identifier: NCT01511575     History of Changes
Other Study ID Numbers: AAML12B3
COG-AAML12B3 ( Other Identifier: Children's Oncology Group )
AAML12B3 ( Other Identifier: Children's Oncology Group )
NCI-2012-00111 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Study First Received: January 13, 2012
Last Updated: May 13, 2016

Keywords provided by Children's Oncology Group:
childhood acute myeloid leukemia in remission
childhood acute myeloid leukemia/other myeloid malignancies
childhood acute megakaryocytic leukemia (M7)

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Down Syndrome
Myeloproliferative Disorders
Leukemoid Reaction
Neoplasms by Histologic Type
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Bone Marrow Diseases
Hematologic Diseases
Leukocyte Disorders processed this record on August 23, 2017