Studying Biomarkers in Samples From Younger Patients With Acute Myeloid Leukemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01642121
First received: July 13, 2012
Last updated: August 23, 2012
Last verified: August 2012
  Purpose

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

PURPOSE: This laboratory study is looking into biomarkers in samples from younger patients with acute myeloid leukemia.


Condition Intervention
Leukemia
Genetic: cytogenetic analysis
Genetic: mutation analysis
Genetic: polymerase chain reaction
Genetic: reverse transcriptase-polymerase chain reaction
Other: flow cytometry
Other: fluorescence activated cell sorting
Other: laboratory biomarker analysis

Study Type: Observational
Official Title: Rapid Identification of Leukemia Stem Cells Associated With AML1-ETO and Inv(16) Through Characterization of Oncogene-Induced Changes in Cell-Surface Antigen Profiles on Hematopoietic Stem Cells

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Identification of LSC subset in a NSG transplantation assay [ Designated as safety issue: No ]
  • Association between biomarker expression and confirmation of the translocation [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: August 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • To address whether the mutation-specific cell-surface markers observed in murine system will allow the prospective isolation of leukemia stem cells (LSC) from human bone marrow samples that have the same cytogenetic abnormalities.
  • To compare the incidence of leukemia in NSG mice that have received CD34+CD38 marker+ cells to NSG mice that receive what are hypothesized to be normal cells (CD34+CD38 marker-subset) from the same patient.

OUTLINE: Samples and controls are sorted and re-sorted for CD34, CD38, and CD55 subsets by single-cell polymerase chain reaction (PCR) analysis, flow cytometry, and reverse-transcriptase PCR. Sorted cell subsets are then transplanted into NSG mice. Beginning 6 weeks after transplantation, peripheral blood samples are collected and analyzed for human lymphoid- and myeloid-lineage cells by fluorescence-activated cell sorting (FACS).

  Eligibility

Ages Eligible for Study:   up to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Frozen bone marrow aspirates obtained from childhood acute myeloid leukemia (AML) patients possessing defined cytogenetic mutations; AML1-ETO or inv(16)
  • Samples of cytogenetically normal AML cases obtained from the University of Alabama at Birmingham (UAB) as controls

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: NCT01642121

Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Stephanie C. Heidemann, MD University of Alabama at Birmingham
  More Information

Additional Information:
No publications provided

Responsible Party: Peter C. Adamson, Children's Oncology Group - Group Chair Office
ClinicalTrials.gov Identifier: NCT01642121     History of Changes
Other Study ID Numbers: CDR0000736625, COG-AAML12B10
Study First Received: July 13, 2012
Last Updated: August 23, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
childhood acute myeloid leukemia/other myeloid malignancies
childhood acute myeloblastic leukemia without maturation (M1)
childhood acute myelomonocytic leukemia (M4)
childhood acute monoblastic leukemia (M5a)
childhood acute monocytic leukemia (M5b)

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

ClinicalTrials.gov processed this record on August 28, 2014