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Prognostic Biomarkers in Samples From Young Patients With Acute Myeloid Leukemia

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01245231
Enrollment
150
Registered
2010-11-22
Start date
2010-05-31
Completion date
Unknown
Last updated
2016-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia

Keywords

childhood acute myeloid leukemia/other myeloid malignancies

Brief summary

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.

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.

Interventions

GENETICprotein expression analysis
GENETICwestern blotting
OTHERflow cytometry
OTHERlaboratory biomarker analysis
OTHERmedical chart review

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Children's Oncology Group
Lead SponsorNETWORK

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 30 Years
Healthy volunteers
No

Inclusion criteria

DISEASE CHARACTERISTICS: * Diagnosis of acute myeloid leukemia (AML) * Cryopreserved AML specimens PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * Not specified

Design outcomes

Primary

MeasureTime frame
Correlation of constitutive pStat3 with inducible pStat3
Correlation of pStat3 responses with pStat5 responses, and G-CSF-induced responses with IL-6- induced responses
Correlation of pStat3- and pStat5-induced responses with surface G-CSFR and gp130 expression
Correlation of constitutive pStat3/pStat5 with levels of the negative regulators SOCS3 and SHP1

Secondary

MeasureTime frame
Correlation between pStat3/pStat5 and event-free survival and overall survival

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026