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Studying Biomarker Expression in Samples From Patients With Down Syndrome and Acute Myeloid Leukemia or Other Transient Myeloproliferative Disorder

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01511575
First received: January 13, 2012
Last updated: February 14, 2012
Last verified: February 2012
History of Changes

January 13, 2012
February 14, 2012
February 2012
March 2012   (final data collection date for primary outcome measure)
Gene expression levels between DS AMKL and non-DS AMKL patients [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01511575 on ClinicalTrials.gov Archive Site
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Studying Biomarker Expression in Samples From Patients With Down Syndrome and Acute Myeloid Leukemia or Other Transient Myeloproliferative Disorder
Analysis of MicroRNA Expression in Down Syndrome Acute Myeloid Leukemia and the Transient Myeloproliferative Disorder

RATIONALE: Studying samples of blood, tissue, and bone marrow from patients with cancer in the laboratory may help doctors learn about changes that occur in RNA and identify biomarkers related to cancer.

PURPOSE: This research trial studies RNA samples from patients with Down syndrome and acute myeloid leukemia or other transient myeloproliferative disorder.

OBJECTIVES:

  • To compare miRNA expression in distinctive diagnostic groups: transient myeloproliferative disorder (TMD), Down syndrome (DS) acute megakaryocytic leukemia (AMkL), non-DS AMkL, and in remission DS samples (representing germline, non-malignant samples).

OUTLINE: Archived RNA samples are analyzed for mature micro (mi)RNA expression by real-time RT-PCR. Results are then compared with miRNA expression of non-Down syndrome patients with acute megakaryocytic leukemia.
Observational
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Leukemia
  • Genetic: RNA analysis
  • Genetic: reverse transcriptase-polymerase chain reaction
  • Other: laboratory biomarker analysis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
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March 2012   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Patients with Down syndrome (DS) diagnosed with acute myeloid leukemia or transient myeloproliferative disorder
  • Clinical samples obtained from patients enrolled on the COG AAML0431 and COG AAML08B1

PATIENT CHARACTERISTICS:

  • Previously consented to biologic studies

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
Both
up to 3 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01511575
CDR0000722054, COG-AAML12B3
Not Provided
Peter C. Adamson, Children's Oncology Group - Group Chair Office
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Jeffrey Taub, MD Children's Hospital of Michigan
National Cancer Institute (NCI)
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP