RNA Biomarkers in Tissue Samples From Infants With Acute Myeloid Leukemia

This study is ongoing, but not recruiting participants.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
First received: October 26, 2010
Last updated: May 11, 2015
Last verified: May 2015

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

PURPOSE: This research study is studying RNA biomarkers in tissue samples from infants with acute myeloid leukemia.

Condition Intervention
Genetic: RNA analysis
Genetic: nucleic acid sequencing
Genetic: reverse transcriptase-polymerase chain reaction
Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: SCOR in Targeted Therapies for Infant Leukemias Project 4: MicroRNA Sequencing of Infant AML

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Sequence of the microRNAs present in 20 infant acute myeloid leukemia (AML) samples [ Designated as safety issue: No ]
  • Comparison of microRNAs present in infant AML samples to infant acute lymphoblastic leukemia samples to identify lineage- and translocation-specific microRNAs [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Estimated Enrollment: 20
Study Start Date: October 2010
Estimated Primary Completion Date: January 2100 (Final data collection date for primary outcome measure)
Detailed Description:


  • Sequence the microRNAs present in 20 infant AML samples as a pilot study.
  • Compare microRNAs present in infant AML samples to infant ALL samples that are being concurrently sequenced in a separate study to identify lineage- and translocation-specific microRNAs.

OUTLINE: This is a multicenter study.

Previously collected cryopreserved cells from diagnosis are sequenced using reverse transcriptase-PCR.


Ages Eligible for Study:   up to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Diagnosis of acute myeloid leukemia.


  • Diagnosis of acute myeloid leukemia
  • Available cryopreserved cells from diagnosis


  • Not specified


  • Not specified
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01229124

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Michael Cleary, MD Stanford University
  More Information

Additional Information:
Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01229124     History of Changes
Other Study ID Numbers: AAML11B1  COG-AAML11B1  NCI-2011-02841  AAML11B1 
Study First Received: October 26, 2010
Last Updated: May 11, 2015
Health Authority: United States: Federal Government

Keywords provided by Children's Oncology Group:
childhood acute myeloid leukemia/other myeloid malignancies

Additional relevant MeSH terms:
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on April 27, 2016