Biomarker Study in Tissue Samples From Patients With Acute Myeloid Leukemia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01232842
First received: October 30, 2010
Last updated: May 11, 2015
Last verified: May 2015
  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
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Assessment of Stem Cell Heterogeneity in AML in Co-Culture Systems Using X Chromosome Inactivation Patterns

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

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 ]

Biospecimen Retention:   Samples With DNA

Tissue


Estimated Enrollment: 20
Study Start Date: October 2010
Estimated Primary Completion Date: January 2100 (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
Sampling Method:   Non-Probability Sample
Study Population

Diagnosed with acute myeloid leukemia.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01232842

Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Roland Walter, MD, PhD Fred Hutchinson Cancer Research Center
  More Information

Additional Information:
No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01232842     History of Changes
Other Study ID Numbers: AAML11B4, COG-AAML11B4, NCI-2011-02843, AAML11B4
Study First Received: October 30, 2010
Last Updated: May 11, 2015
Health Authority: United States: Federal Government

Keywords provided by Children's Oncology Group:
adult acute myeloid leukemia
childhood acute myeloid leukemia/other myeloid malignancies

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

ClinicalTrials.gov processed this record on August 27, 2015