RNA Biomarkers in Tissue Samples From Infants With Acute Myeloid Leukemia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01229124
First received: October 26, 2010
Last updated: May 11, 2015
Last verified: May 2015
  Purpose

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
Leukemia
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

Tissue


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

OBJECTIVES:

  • 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.

  Eligibility

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.

Criteria

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • 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 ClinicalTrials.gov identifier: NCT01229124

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

Additional Information:
No publications provided

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
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on May 26, 2015