NCT01150058

Brief Summary

RATIONALE: Studying cell samples 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 studying drug 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
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2010

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

June 23, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 24, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

May 12, 2015

Status Verified

May 1, 2015

Enrollment Period

2 years

First QC Date

June 23, 2010

Last Update Submit

May 11, 2015

Conditions

Keywords

adult acute myeloid leukemia with 11q23 (MLL) abnormalitiesadult acute myeloid leukemia with del(5q)adult acute myeloid leukemia with inv(16)(p13;q22)adult acute myeloid leukemia with t(15;17)(q22;q12)adult acute myeloid leukemia with t(16;16)(p13;q22)adult acute myeloid leukemia with t(8;21)(q22;q22)childhood acute myeloid leukemia/other myeloid malignanciesadult acute myeloid leukemia

Outcome Measures

Primary Outcomes (2)

  • Activity of novel CD33-targeting immunoconjugate agents

  • Genotypic characteristics of acute myeloid leukemia cells

Interventions

Eligibility Criteria

AgeUp to 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients With Acute Myeloid Leukemia

DISEASE CHARACTERISTICS: * Diagnosis of acute myeloid leukemia * Cryopreserved samples available 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

LeukemiaCongenital AbnormalitiesLeukemia, Myeloid, Acute

Interventions

Blotting, WesternFlow Cytometry

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLeukemia, Myeloid

Intervention Hierarchy (Ancestors)

ElectrophoresisChemistry Techniques, AnalyticalInvestigative TechniquesElectrochemical TechniquesImmunoblottingImmunoassayImmunologic TechniquesMolecular Probe TechniquesCell SeparationCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisCytophotometryFluorometryLuminescent MeasurementsPhotometry

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

June 23, 2010

First Posted

June 24, 2010

Study Start

November 1, 2010

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

May 12, 2015

Record last verified: 2015-05