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OpenTrials
Completed

NCT Number: NCT01245231

Prognostic Biomarkers in Samples From Young Patients With Acute Myeloid Leukemia

RATIONALE: Studying samples of blood or tumor 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. It may also help doctors predict how patients will respond to treatment.

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

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Key information

Conditions

Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Neoplasms Neoplasms by Histologic Type

Age range

Up to 30 year

Sex eligibility

All sexes

Study type

Observational

About this study

OBJECTIVES:

Primary

  • To determine the percentage of primary acute myeloid leukemia (AML) samples with increased Stat3 signaling pathway activity.
  • To evaluate the presence of constitutive Stat3 activation and the sensitivity of Stat3 activation to low- and high-doses of cytokines.
  • To evaluate the expression levels of Stat3 protein and the upstream and downstream regulators of Stat3 activation.

Secondary

  • To classify samples according to a Stat3 activation pattern and correlate this result with event-free survival (EFS) and overall survival (OS).

OUTLINE: Cryopreserved AML specimens are analyzed for pStat3 and pStat5 levels, response to cytokine levels, and expression level of proteins known to influence stat activity by flow cytometry and western blot assays. Results are also compared with prognostic variables determined in CCG-291 study, including age, race, WBC, and cytogenetic risks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

DISEASE CHARACTERISTICS:

  • Diagnosis of acute myeloid leukemia (AML)
  • Cryopreserved AML specimens

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified

Treatment and study plan

protein expression analysis

Genetic

western blotting

Genetic

flow cytometry

Other

laboratory biomarker analysis

Other

medical chart review

Other

Primary outcomes

  1. Correlation of constitutive pStat3 with inducible pStat3

  2. Correlation of pStat3 responses with pStat5 responses, and G-CSF-induced responses with IL-6- induced responses

  3. Correlation of pStat3- and pStat5-induced responses with surface G-CSFR and gp130 expression

  4. Correlation of constitutive pStat3/pStat5 with levels of the negative regulators SOCS3 and SHP1

Secondary outcomes

  1. Correlation between pStat3/pStat5 and event-free survival and overall survival

Sponsors and collaborators

Lead sponsor

Children's Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Stat3 Activation as a Potential Prognostic Marker and Therapeutic Target in Pediatric AML-II

Important dates

Study start
2010
Primary completion
2016
First posted
Nov 22, 2010
Registry last updated
May 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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