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Studying Genes in Samples From Younger Patients With Acute Megakaryoblastic Leukemia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01642069
First received: July 15, 2012
Last updated: July 27, 2012
Last verified: July 2012
History of Changes
  Purpose

RATIONALE: Studying samples of blood, tissue, and bone marrow 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 laboratory study is looking into genes in samples from younger patients with acute megakaryoblastic leukemia (AMKL).


Condition Intervention
Leukemia
 Genetic: RNA analysis
Genetic: fluorescence in situ hybridization
Genetic: gene expression analysis
Genetic: gene rearrangement analysis
Genetic: reverse transcriptase-polymerase chain reaction
Other: laboratory biomarker analysis

Study Type: Observational
Official Title: NUP98/JARID1A as a Recurrent Aberration in Pediatric Acute Megakaryoblastic Leukemia

Resource links provided by NLM:

MedlinePlus related topics: Cancer Leukemia
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • NUP98/JARID1A as a recurrent aberration in pediatric AMKL [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: July 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • To determine whether NUP98/JARID1A expression is a recurrent translocation in NUP98-rearranged cases in pediatric acute megakaryoblastic leukemia (AMKL).
  • To screen the Children Oncology Group (COG) samples for genetic aberrations in pediatric AMKL.

OUTLINE: Cryopreserved specimens are analyzed for NUP98 fusion to NSD1, JARID1A, and TOP1, myeloid/lymphoid or mixed-lineage leukemia (MLL)-rearrangements, and other gene expression profiling by reverse-transcriptase polymerase chain reaction (RT-PCR) and karyotyping or fluorescence in situ hybridization ( FISH). Results are then compared with each patient's outcome data.

  Eligibility

Ages Eligible for Study:   up to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Cryopreserved specimens of pediatric patients diagnosed with acute megakaryoblastic leukemia

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01642069

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Soheil Meshinchi, MD Fred Hutchinson Cancer Research Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Peter C. Adamson, Children's Oncology Group - Group Chair Office
ClinicalTrials.gov Identifier: NCT01642069     History of Changes
Other Study ID Numbers: CDR0000736633, COG-AAML12B9
Study First Received: July 15, 2012
Last Updated: July 27, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
childhood acute megakaryocytic leukemia (M7)
childhood acute myeloid leukemia/other myeloid malignancies

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

ClinicalTrials.gov processed this record on May 19, 2013