CompletedNCT01057290Updated May 18, 2016

Studying Biomarkers in Cell Samples From Young Patients With Acute Myeloid Leukemia

An observational study in Leukemia, sponsored by Children's Oncology Group. Completed. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2016-05-18.

Sponsored by Children's Oncology Group · Observational

Study type: Observational
Model: Case-control
Time perspective: Retrospective
Enrollment: 75
Ages: Up to 18 Years
Sex: All

Study 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. It may also help doctors predict how well patients will respond to treatment.

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

Read the detailed description

OBJECTIVES:

To characterize Stat3 signaling pathway activity in primary tissue samples from pediatric patients with acute myeloid leukemia to determine the percentage of samples with increased activity and to better understand the mechanisms leading to increased 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 as well as upstream and downstream regulators of Stat3 activation.
To classify tissue samples according to a Stat3-activation pattern, and to correlate this result with event-free survival and overall survival in order to determine whether increased Stat3 phosphorylation at diagnosis predicts poor outcome.

OUTLINE: Cryopreserved cell samples are collected for laboratory analysis, including immunoblotting, fluorescence activated cell sorting (FACS), and protein analysis.

Conditions studied

Leukemia

Browse trials for

Leukemia 5,475

Keywords

childhood acute myeloid leukemia/other myeloid malignancies

In context

Leukemia

5,475 studies on the registry are indexed under Leukemia; 629 are open to participants now.

This study's planned enrollment of 75 is below the median of 120 across 747 observational studies indexed under Leukemia.

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Lead sponsor

Children's Oncology Group is the lead sponsor of 447 studies on the registry; 35 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 11 (92%) have results posted.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Up to 18 Years
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

Diagnosis of pediatric acute myeloid leukemia

Eligibility criteria

DISEASE CHARACTERISTICS:

Diagnosis of pediatric acute myeloid leukemia

PATIENT CHARACTERISTICS:

Not specified

PRIOR CONCURRENT THERAPY:

Not specified

Study design

Observational model: Case-control
Time perspective: Retrospective
Enrollment: 75 participants (estimated)
Patient registry: No
Biospecimen retention: Samples with dna

Interventions

Geneticgene expression analysis
Geneticprotein expression analysis
Otherfluorescence activated cell sorting
Otherimmunologic technique
Otherlaboratory biomarker analysis

What researchers measure

Primary outcomes

Correlation of the Stat3 response category (constitutive, low-dose responsive, high-dose responsive, or unresponsive) with clinical data, including event-free and overall survival

Study locations

No study locations are listed for this record.

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2012 and a primary completion of May 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered: Jan 26, 2010
First posted: Jan 27, 2010
Start: Sep 2012
Primary completionActual: May 2016
Last update: May 18, 2016

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on May 18, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01057290
Lead sponsor: Children's Oncology Group
Collaborators: National Cancer Institute (NCI)
Responsible party: Sponsor
First posted: Jan 27, 2010
Start date: Sep 2012
Primary completion: May 2016
Last update: May 18, 2016

Study contacts

Michele S. Redell, MD, PhD

principal investigator · Texas Children's Cancer Center

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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