NCT01229956

Brief Summary

RATIONALE: Studying samples of tissue from patients with cancer the in laboratory may help doctors identify and 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
32

participants targeted

Target at P25-P50 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

October 27, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 2010

Completed
4 days until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Last Updated

May 19, 2016

Status Verified

May 1, 2016

Enrollment Period

5.5 years

First QC Date

October 27, 2010

Last Update Submit

May 17, 2016

Conditions

Leukemia

Keywords

childhood acute myeloid leukemia in remissionrecurrent childhood acute myeloid leukemiauntreated childhood acute myeloid leukemia and other myeloid malignancies

Outcome Measures

Primary Outcomes (1)

  • Identification of differential patterns of promoter hypermethylation and gene expression in pairwise comparisons with other cohorts and normal controls

Interventions

DNA methylation analysisGENETIC
gene expression analysisGENETIC
microarray analysisGENETIC
reverse transcriptase-polymerase chain reactionGENETIC
laboratory biomarker analysisOTHER

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients With Acute Myeloid Leukemia.

DISEASE CHARACTERISTICS: * Available cryopreserved cells from diagnosis * At least 2 x 10\^7 viably cryopreserved cells * One of the following biologically defined cytogenetics/molecular cohorts: * t(9;11) * t(11;19) * Other 11q23 translocations * Normal cytogenetics 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

Tissue

MeSH Terms

Conditions

Leukemia

Interventions

DNA MethylationGene Expression ProfilingMicroarray AnalysisReverse Transcriptase Polymerase Chain Reaction

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

MethylationAlkylationBiochemical PhenomenaChemical PhenomenaMetabolismGenetic PhenomenaGenetic TechniquesInvestigative TechniquesMicrochip Analytical ProceduresPolymerase Chain ReactionNucleic Acid Amplification Techniques

Study Officials

  • Patrick N. Brown, MD

    CHRISTUS Santa Rosa Cancer Center at CHRISTUS Santa Rosa Hospital - City Centre

    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

October 27, 2010

First Posted

October 28, 2010

Study Start

November 1, 2010

Primary Completion

May 1, 2016

Last Updated

May 19, 2016

Record last verified: 2016-05