NCT01057199

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 cell samples from patients with acute myeloid leukemia.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2010

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

January 1, 2010

Completed
25 days until next milestone

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
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

May 7, 2015

Status Verified

May 1, 2015

Enrollment Period

5 months

First QC Date

January 26, 2010

Last Update Submit

May 5, 2015

Conditions

Leukemia

Keywords

adult acute myeloid leukemiachildhood acute myeloid leukemia/other myeloid malignancies

Outcome Measures

Primary Outcomes (4)

  • Significance of regulation of microRNA-34a and microRNA-194 by C/EBPα during granulopoiesis

  • Relationship between overexpression of microRNA-34a and microRNA-194 in myeloid progenitors with C/EBPα mutations and granulocytic differentiation

  • Downregulation of E2F3 by microRNA-34a and microRNA-194 during granulopoiesis

  • Role of microRNA-34a and microRNA-194 in myeloid cell proliferation

Interventions

RNA analysisGENETIC
gene expression analysisGENETIC
mutation analysisGENETIC
protein expression analysisGENETIC
fluorescence activated cell sortingOTHER
laboratory biomarker analysisOTHER

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Diagnosis of acute myeloid leukemia with CEBPA mutations

DISEASE CHARACTERISTICS: * Diagnosis of acute myeloid leukemia with CEBPA mutations 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

LeukemiaLeukemia, Myeloid, Acute

Interventions

Gene Expression ProfilingFlow Cytometry

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, Myeloid

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Soheil Meshinchi, MD

    Fred Hutchinson 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

January 26, 2010

First Posted

January 27, 2010

Study Start

January 1, 2010

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

May 7, 2015

Record last verified: 2015-05