NCT01232842

Brief Summary

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

participants targeted

Target at below P25 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, 2010

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

October 30, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 2, 2010

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Last Updated

July 11, 2016

Status Verified

July 1, 2016

Enrollment Period

5.8 years

First QC Date

October 30, 2010

Last Update Submit

July 7, 2016

Conditions

Leukemia

Keywords

adult acute myeloid leukemiachildhood acute myeloid leukemia/other myeloid malignancies

Outcome Measures

Primary Outcomes (2)

  • Frequency of AML that originate in CD33+ or in which uncontrolled growth is restricted to CD33+ precursors

  • Extent of clonal hematopoiesis in small numbers of AML cells

Interventions

cytogenetic analysisGENETIC
HUMARA assayOTHER
fluorescence activated cell sortingOTHER
laboratory biomarker analysisOTHER

Eligibility Criteria

AgeUp to 120 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Diagnosed with acute myeloid leukemia.

DISEASE CHARACTERISTICS: * Diagnosed with acute myeloid leukemia * Known CD34+ progenitor cells * Available freshly isolated, uncultured cell samples 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

LeukemiaLeukemia, Myeloid, Acute

Interventions

Cytogenetic AnalysisFlow Cytometry

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, Myeloid

Intervention Hierarchy (Ancestors)

Cytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesGenetic TechniquesCell SeparationCytophotometryFluorometryLuminescent MeasurementsPhotometryChemistry Techniques, Analytical

Study Officials

  • Roland Walter, MD, PhD

    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

October 30, 2010

First Posted

November 2, 2010

Study Start

October 1, 2010

Primary Completion

July 1, 2016

Last Updated

July 11, 2016

Record last verified: 2016-07