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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
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
  Purpose

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.


Condition Intervention
Leukemia
Genetic: RNA analysis
Genetic: reverse transcriptase-polymerase chain reaction
Other: laboratory biomarker analysis

Study Type: Observational
Official Title: Analysis of MicroRNA Expression in Down Syndrome Acute Myeloid Leukemia and the Transient Myeloproliferative Disorder

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Gene expression levels between DS AMKL and non-DS AMKL patients [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: February 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 3 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01511575

Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Jeffrey Taub, MD Children's Hospital of Michigan
  More Information

Additional Information:
No publications provided

Responsible Party: Peter C. Adamson, Children's Oncology Group - Group Chair Office
ClinicalTrials.gov Identifier: NCT01511575     History of Changes
Other Study ID Numbers: CDR0000722054, COG-AAML12B3
Study First Received: January 13, 2012
Last Updated: February 14, 2012
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Down Syndrome
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Myeloproliferative Disorders
Mental Retardation
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases

ClinicalTrials.gov processed this record on July 24, 2014