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Biomarker Study in Tissue Samples From Patients With Acute Myeloid Leukemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01232842
First received: October 30, 2010
Last updated: February 4, 2011
Last verified: February 2011
History of Changes
  Purpose

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

PURPOSE: This research study is studying biomarkers in tissue samples from patients with acute myeloid leukemia.


Condition Intervention
Leukemia
 Genetic: cytogenetic analysis
Other: HUMARA assay
Other: fluorescence activated cell sorting
Other: laboratory biomarker analysis

Study Type: Observational
Official Title: Assessment of Stem Cell Heterogeneity in AML in Co-Culture Systems Using X Chromosome Inactivation Patterns

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Frequency of AML that originate in CD33+ or in which uncontrolled growth is restricted to CD33+ precursors [ Designated as safety issue: No ]
  • Extent of clonal hematopoiesis in small numbers of AML cells [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: October 2010
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the frequency of acute myeloid leukemia (AML) that originates in CD33+ precursors or in which uncontrolled growth is restricted to CD33+ precursors.

OUTLINE: Cryopreserved acute myeloid leukemia cell samples are separated from endothelial cell by fluorescent-activated cell sorting (FACS) and analyzed for X-chromosome inactivation patterns by cytogenetic/molecular analysis and/or Humara assay.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosed with acute myeloid leukemia
  • Known CD34+ progenitor cells
  • Available freshly isolated, uncultured cell samples

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01232842

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Roland Walter, MD, PhD 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: Gregory H. Reaman, Children's Oncology Group - Group Chair Office
ClinicalTrials.gov Identifier: NCT01232842     History of Changes
Other Study ID Numbers: CDR0000687880, COG-AAML11B4
Study First Received: October 30, 2010
Last Updated: February 4, 2011
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on May 22, 2013