Biomarkers in Young Patients With Acute Myeloid Leukemia

Leukemia Clinical Trial

Official title:

Stat3 Signaling Pathway Aberrancies in Pediatric AML

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01138332
• Other study ID #: AAML10B10
• Secondary ID: COG-AAML10B10CDR
• Status: Completed
• Phase: N/A
• First received: June 4, 2010
• Last updated: May 5, 2015
• Start date: September 2009
• Est. completion date: March 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 biomarkers related to cancer.

PURPOSE: This research study is studying biomarkers in tissue samples from young patients with acute myeloid leukemia.

Description:

OBJECTIVES:

• Determine the frequency of ligand-independent phosphorylation of Stat3 in a small cohort of samples from pediatric patients with acute myeloid leukemia including, but not limited to, samples known to express mutated c-kit.

• Measure the level of Stat3 phosphorylation in these samples after stimulation of three key cytokine receptors expressed on hematopoietic cells IL-6R, G-CSFR, and c-kit.

OUTLINE: Cryopreserved samples are analyzed for levels of various components of the Stat3 pathway via western blotting.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 21 Years

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosis of acute myeloid leukemia

• One of the following karyotypes:

• t(8;21) and WT c-kit

• t(8;21) and mutant c-kit

• Normal karyotype

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, Acute

Intervention

Genetic:
• western blotting

Other:
• 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	Correlations between levels of pY-Stat3 and levels of upstream cytokine receptors			No
Primary	Association of constitutive and/or increased pY-Stat3 and c-kit genotype			No