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NCT01251159 Clinical Trial

Biomarkers in Bone Marrow Samples From Patients With Acute Myeloid Leukemia

Leukemia Clinical Trial

Official title:
Somatic Mutations in Stem and Progenitor Cells in AML

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01251159
Other study ID # CDR0000688223
Secondary ID ECOG-E1900T4
Status Completed
Phase N/A
First received November 30, 2010
Last updated May 16, 2017
Start date May 15, 2009
Est. completion date June 15, 2009

Study information
Verified date May 2017
Source Eastern Cooperative Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Description:

OBJECTIVES:

- 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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date June 15, 2009
Est. primary completion date June 15, 2009
Accepts healthy volunteers No
Gender All
Age group 16 Years to 60 Years
Eligibility DISEASE CHARACTERISTICS:

- 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

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- Not specified

Study Design

Related Conditions & MeSH terms

Intervention

Genetic:
• mutation analysis

• polymerase chain reaction

Other:
• immunologic technique

• laboratory biomarker analysis

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
ECOG-ACRIN Cancer Research Group National Cancer Institute (NCI)

Outcome
Type Measure Description Time frame Safety issue
Primary Define somatic mutations occurring in de novo AML 1 month
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