NCT01138332

Brief Summary

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about biomarkers related to cancer. PURPOSE: This research study is studying biomarkers in tissue 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
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2009

Shorter than P25 for all trials

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 7, 2010

Completed
Last Updated

May 6, 2015

Status Verified

May 1, 2015

Enrollment Period

6 months

First QC Date

June 4, 2010

Last Update Submit

May 5, 2015

Conditions

Leukemia

Keywords

childhood acute myeloid leukemia/other myeloid malignancies

Outcome Measures

Primary Outcomes (2)

  • Correlations between levels of pY-Stat3 and levels of upstream cytokine receptors

  • Association of constitutive and/or increased pY-Stat3 and c-kit genotype

Interventions

western blottingGENETIC
laboratory biomarker analysisOTHER

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Diagnosis of acute myeloid leukemia

DISEASE CHARACTERISTICS: * Diagnosis of acute myeloid leukemia * One of the following karyotypes: * t(8;21) and WT c-kit * t(8;21) and mutant c-kit * Normal karyotype 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

MeSH Terms

Conditions

Leukemia

Interventions

Blotting, Western

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

ElectrophoresisChemistry Techniques, AnalyticalInvestigative TechniquesElectrochemical TechniquesImmunoblottingImmunoassayImmunologic TechniquesMolecular Probe Techniques

Study Officials

  • Michele S. Redell, MD, PhD

    Texas Children's Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 4, 2010

First Posted

June 7, 2010

Study Start

September 1, 2009

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

May 6, 2015

Record last verified: 2015-05