Studying Biomarkers in Cell Samples From Patients With Acute Myeloid Leukemia

Leukemia Clinical Trial

Official title:

Critical Role of MicroRNA-34a and MicroRNA-194 in Acute Myeloid Leukemia With CEBPA Mutations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01057199
• Other study ID #: AAML10B13
• Secondary ID: COG-AAML10B13CDR
• Status: Completed
• Phase: N/A
• First received: January 26, 2010
• Last updated: May 5, 2015
• Start date: January 2010
• Est. completion date: June 2010

Study information

• Verified date: May 2015
• Source: Children's Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

RATIONALE: Studying samples of tissue 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 research study is looking at biomarkers in cell samples from patients with acute myeloid leukemia.

Description:

OBJECTIVES:

• To determine the significance of regulation of microRNA-34a and microRNA-194 by C/EBPα during granulopoiesis in patients with acute myeloid leukemia with CEBPA mutations.

• To determine whether overexpression of micro RNA-34a and microRNA-194 in myeloid progenitors with C/EBPα mutations leads to granulocytic differentiation.

• To examine how microRNA-34a and microRNA-194 downregulate E2F3 during granulopoiesis.

• To determine the role of microRNA-34a and microRNA-194 in myeloid cell proliferation.

OUTLINE: Cryopreserved cell samples are collected for laboratory analysis, including mutation analysis, gene expression analysis, RNA analysis, and fluorescence-activated cell sorting (FACS) analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosis of acute myeloid leukemia with CEBPA mutations

PATIENT CHARACTERISTICS:

• Not specified

PRIOR CONCURRENT THERAPY:

• Not specified

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Genetic:
• RNA analysis

• gene expression analysis

• mutation analysis

• protein expression analysis

Other:
• fluorescence activated cell sorting

• laboratory biomarker analysis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Children's Oncology Group	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Significance of regulation of microRNA-34a and microRNA-194 by C/EBPa during granulopoiesis			No
Primary	Relationship between overexpression of microRNA-34a and microRNA-194 in myeloid progenitors with C/EBPa mutations and granulocytic differentiation			No
Primary	Downregulation of E2F3 by microRNA-34a and microRNA-194 during granulopoiesis			No
Primary	Role of microRNA-34a and microRNA-194 in myeloid cell proliferation			No