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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01511575
Recruitment Status : Completed
First Posted : January 18, 2012
Last Update Posted : May 17, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Brief Summary:

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 or disease Intervention/treatment
Leukemia Genetic: RNA analysis Genetic: reverse transcriptase-polymerase chain reaction Other: laboratory biomarker analysis

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.

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Analysis of MicroRNA Expression in Down Syndrome Acute Myeloid Leukemia and the Transient Myeloproliferative Disorder
Study Start Date : February 2012
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01511575

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

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Responsible Party: Children's Oncology Group Identifier: NCT01511575    
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) )
First Posted: January 18, 2012    Key Record Dates
Last Update Posted: May 17, 2016
Last Verified: May 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:
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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Down Syndrome
Myeloproliferative Disorders
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