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 Information
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
Administrative Informations
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