Studying Genes in Samples From Younger Patients With Acute Megakaryoblastic Leukemia

Brief Title

Studying Genes in Samples From Younger Patients With Acute Megakaryoblastic Leukemia

Official Title

Observational - NUP98/JARID1A as a Recurrent Aberration in Pediatric Acute Megakaryoblastic Leukemia

Brief Summary

      This laboratory study is looking into genes in samples from younger patients with acute
      megakaryoblastic leukemia (AMKL). 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
    

Detailed Description

      Study Subtype: Ancillary/Correlative Observational Study Model: Cohort Time Perspective:
      Retrospective Biospecimen Retention: Samples With DNA Biospecimen Description: Cryopreserved
      mRNA Study Population Description: Samples from AAML0531 Sampling Method: Non-Probability
      Sample

      OBJECTIVES:

      I. To determine whether NUP98/JARID1A expression is a recurrent translocation in
      NUP98-rearranged cases in pediatric acute megakaryoblastic leukemia (AMKL).

      II. 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.
    

Study Type

Observational

Primary Outcome

Complete remission (CR, defined as less than 5% blasts in the bone marrow, with regeneration of tri-lineage hematopoiesis, plus absence of leukemic cells in the cerebrospinal fluid or elsewhere)

Condition

Childhood Acute Megakaryocytic Leukemia (M7)

Intervention

laboratory biomarker analysis

Study Arms / Comparison Groups

 Observational

Description:  Cryopreserved specimens are analyzed for NUP98 fusion to NSD1, JARID1A, and TOP1, myeloid/lymphoid or MLL-rearrangements, and other gene expression profiling by RT-PCR and karyotyping or FISH. Results are then compared with each patient's outcome data.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Other

Estimated Enrollment

100

Start Date

July 2012

Completion Date

May 2016

Primary Completion Date

May 2016

Eligibility Criteria

        Inclusion Criteria:

          -  Cryopreserved specimens of pediatric patients diagnosed with acute megakaryoblastic
             leukemia
      

Gender

All

Ages

N/A - 30 Years

Accepts Healthy Volunteers

No

Contacts

Soheil Meshinchi, MD, , 

Location Countries

United States

Location Countries

United States

NCT ID

NCT01642069

Organization ID

AAML12B9

Secondary IDs

NCI-2012-01984

Responsible Party

Sponsor

Study Sponsor

Children's Oncology Group

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Soheil Meshinchi, MD, Principal Investigator, Children's Oncology Group

Verification Date

May 2016