NCT01057290

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 27, 2010

Completed
2.6 years until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Last Updated

May 18, 2016

Status Verified

May 1, 2016

Enrollment Period

3.7 years

First QC Date

January 26, 2010

Last Update Submit

May 17, 2016

Conditions

Leukemia

Keywords

childhood acute myeloid leukemia/other myeloid malignancies

Outcome Measures

Primary Outcomes (1)

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

Interventions

gene expression analysisGENETIC
protein expression analysisGENETIC
fluorescence activated cell sortingOTHER
immunologic techniqueOTHER
laboratory biomarker analysisOTHER

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Diagnosis of pediatric acute myeloid leukemia

DISEASE CHARACTERISTICS: * Diagnosis of pediatric acute myeloid leukemia PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

cell samples

MeSH Terms

Conditions

Leukemia

Interventions

Gene Expression ProfilingFlow CytometryImmunologic Techniques

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Genetic TechniquesInvestigative TechniquesCell SeparationCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisCytophotometryFluorometryLuminescent MeasurementsPhotometryChemistry Techniques, Analytical

Study Officials

  • Michele S. Redell, MD, PhD

    Texas Children's Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2010

First Posted

January 27, 2010

Study Start

September 1, 2012

Primary Completion

May 1, 2016

Last Updated

May 18, 2016

Record last verified: 2016-05