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Prognostic Biomarkers in Samples From Young Patients With Acute Myeloid Leukemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01245231
First received: November 19, 2010
Last updated: February 9, 2011
Last verified: February 2011
History of Changes
  Purpose

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.


Condition Intervention
Leukemia
 Genetic: protein expression analysis
Genetic: western blotting
Other: flow cytometry
Other: laboratory biomarker analysis
Other: medical chart review

Study Type: Observational
Official Title: Stat3 Activation as a Potential Prognostic Marker and Therapeutic Target in Pediatric AML-II

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Correlation of constitutive pStat3 with inducible pStat3 [ Designated as safety issue: No ]
  • Correlation of pStat3 responses with pStat5 responses, and G-CSF-induced responses with IL-6- induced responses [ Designated as safety issue: No ]
  • Correlation of pStat3- and pStat5-induced responses with surface G-CSFR and gp130 expression [ Designated as safety issue: No ]
  • Correlation of constitutive pStat3/pStat5 with levels of the negative regulators SOCS3 and SHP1 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation between pStat3/pStat5 and event-free survival and overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: November 2010
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01245231

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Michele S. Redell, MD, PhD Texas Children's Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Gregory H. Reaman, Children's Oncology Group - Group Chair Office
ClinicalTrials.gov Identifier: NCT01245231     History of Changes
Other Study ID Numbers: CDR0000689410, COG-AAML11B6
Study First Received: November 19, 2010
Last Updated: February 9, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
childhood acute myeloid leukemia/other myeloid malignancies

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on May 16, 2013