Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

RNA Biomarkers in Tissue Samples From Infants With Acute Myeloid Leukemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: October 26, 2010
Last updated: February 4, 2011
Last verified: February 2011

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
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 National Cancer Institute (NCI):

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 ]

Estimated Enrollment: 20
Study Start Date: October 2010
Estimated Primary Completion Date: January 2011 (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


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


  • Not specified


  • Not specified
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01229124

Sponsors and Collaborators
Children's Oncology Group
Principal Investigator: Michael Cleary, MD Stanford University
  More Information

Additional Information:
No publications provided

Responsible Party: Gregory H. Reaman, Children's Oncology Group - Group Chair Office Identifier: NCT01229124     History of Changes
Other Study ID Numbers: CDR0000687628, COG-AAML11B1
Study First Received: October 26, 2010
Last Updated: February 4, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
childhood acute myeloid leukemia/other myeloid malignancies processed this record on March 03, 2015