NCT01035307

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. PURPOSE: This research study is looking at biomarkers in tissue samples from young patients with acute myeloid leukemia previously enrolled on clinical trial POG-9421.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
90

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

Study Start

First participant enrolled

October 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 18, 2009

Completed
6.4 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

6.6 years

First QC Date

December 17, 2009

Last Update Submit

May 17, 2016

Conditions

Leukemia

Keywords

childhood acute myeloid leukemia in remissionrecurrent childhood acute myeloid leukemia

Outcome Measures

Primary Outcomes (3)

  • Profiling of basal and potentiated phospho-protein networks (PPPNs) using tissue samples

  • Classification of AML-based signal transduction mechanisms

  • Correlation of basal and PPPN profiles with specific molecular lesions (e.g., FLT3-ITD, NPM, WT1, c-kit, CEPBα, PASGΔ75, and karyotype) and gene expression profiles.

Study Arms (1)

Genomic and Proteomic Profiling

Genetic: gene expression analysisGenetic: microarray analysisGenetic: proteomic profilingOther: laboratory biomarker analysis

Interventions

gene expression analysisGENETIC
Genomic and Proteomic Profiling
microarray analysisGENETIC
Genomic and Proteomic Profiling
proteomic profilingGENETIC
Genomic and Proteomic Profiling
laboratory biomarker analysisOTHER
Genomic and Proteomic Profiling

Eligibility Criteria

AgeUp to 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Previously enrolled on POG 9421

DISEASE CHARACTERISTICS: * Diagnosis of acute myeloid leukemia, meeting 1 of the following criteria: * Primary induction failure (i.e., failed to achieve remission within the first 60 days of therapy) * Relapsed disease (early or late) * In continuous complete remission * Previously enrolled on POG-9421 * Tissue samples available PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * See Disease Characteristics

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

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Collected for laboratory studies, including phospho-protein signaling and gene expression profiling studies.

MeSH Terms

Conditions

Leukemia

Interventions

Gene Expression ProfilingMicroarray Analysis

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Genetic TechniquesInvestigative TechniquesMicrochip Analytical Procedures

Study Officials

  • Norman J. Lacayo, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 17, 2009

First Posted

December 18, 2009

Study Start

October 1, 2009

Primary Completion

May 1, 2016

Last Updated

May 18, 2016

Record last verified: 2016-05