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Biomarkers in Bone Marrow Samples From Patients With Acute Myeloid Leukemia

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2010 by National Cancer Institute (NCI).
Recruitment status was:  Not yet recruiting
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: November 30, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted

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 studying bone marrow samples from patients with acute myeloid leukemia.

Condition Intervention
Genetic: mutation analysis
Genetic: polymerase chain reaction
Other: immunologic technique
Other: laboratory biomarker analysis

Study Type: Observational
Official Title: Somatic Mutations in Stem and Progenitor Cells in AML

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Define somatic mutations occurring in de novo AML
  • Selected mutations and order occurrence
  • Identification of antecedent clonal subpopulations with AML mutations that occur earlier in pathogenesis but not in later pathogenesis

Estimated Enrollment: 30
Study Start Date: September 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Detailed Description:


  • To rigorously examine fractionated hematopoietic stem and progenitor cells from patients with acute myeloid leukemia (AML).
  • To define somatic mutations occurring in de novo AML, including the FLT3-ITD, CEBPA, NPM1, TET2, ASXL1, IDH1, and IDH2 mutations.
  • To examine what cellular compartments (LT-HSC, ST-HSC, CMP, GMP, and MEP) contain the selected mutations and in what order those mutations occur.

OUTLINE: Archived bone marrow specimens are analyzed for sequencing and detection of mutations by Sanger-based resequencing of PCR amplicons. Results are then compared with the results of age-matched healthy controls.


Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of acute myeloid leukemia
  • Bone marrow samples must meet 1 of the following criteria:

    • Normal karyotype from patients enrolled on ECOG-1900 archived at the ECOG Leukemia Tissue Bank

      • Live, sortable mononuclear cells prepared at the time of initial diagnosis (slow-frozen in media with 10% DMSO OR fresh cells shipped immediately
    • Age-matched healthy control samples from commercial providers


  • Not specified


  • Not specified
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Please refer to this study by its identifier: NCT01251159

Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Ulrich G. Steidl, MD, BS Albert Einstein College of Medicine, Inc.
  More Information

Responsible Party: Robert L. Comis, ECOG Group Chair's Office Identifier: NCT01251159     History of Changes
Other Study ID Numbers: CDR0000688223
Study First Received: November 30, 2010
Last Updated: November 30, 2010

Keywords provided by National Cancer Institute (NCI):
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with del(5q)
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
untreated adult acute myeloid leukemia
adult acute minimally differentiated myeloid leukemia (M0)
adult acute myeloblastic leukemia with maturation (M2)
adult acute myeloblastic leukemia without maturation (M1)
adult acute myelomonocytic leukemia (M4)
adult acute monoblastic leukemia (M5a)
adult acute monocytic leukemia (M5b)
adult erythroleukemia (M6a)
adult pure erythroid leukemia (M6b)
adult acute megakaryoblastic leukemia (M7)

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms processed this record on April 26, 2017