NCT00900380

Brief Summary

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about cancer and the development of drug resistance in patients. PURPOSE: This laboratory study is examining tissue samples from patients with acute myeloid leukemia to learn more about drug resistance in these patients.

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 Mar 2006

Longer than 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

March 28, 2006

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2013

Completed
Last Updated

May 19, 2017

Status Verified

May 1, 2017

Enrollment Period

7.8 years

First QC Date

May 9, 2009

Last Update Submit

May 17, 2017

Conditions

Keywords

adult acute monocytic leukemia (M5b)adult acute megakaryoblastic leukemia (M7)adult acute myeloblastic leukemia with maturation (M2)adult acute myeloblastic leukemia without maturation (M1)adult acute myelomonocytic leukemia (M4)adult acute monoblastic leukemia (M5a)secondary acute myeloid leukemiauntreated adult acute myeloid leukemiaadult acute minimally differentiated myeloid leukemia (M0)adult acute myeloid leukemia with 11q23 (MLL) abnormalitiesadult acute myeloid leukemia with inv(16)(p13;q22)adult acute myeloid leukemia with t(16;16)(p13;q22)adult acute myeloid leukemia with t(8;21)(q22;q22)adult erythroleukemia (M6a)adult pure erythroid leukemia (M6b)

Outcome Measures

Primary Outcomes (1)

  • Percentage of specimens collected from patients that are found to be P-glycoprotein (P-gp)-positive by accumulation assay that were found to be negative using efflux assay

    1 day

Interventions

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Samples submitted for research from patients participating in E3999

DISEASE CHARACTERISTICS: * Cryopreserved bone marrow specimens collected from patients with acute myeloid leukemia enrolled on clinical trial ECOG-E3999 meeting the following criteria: * Appreciable levels of either CD34+ OR CD117+ blasts * Appreciable staining with anti-P-gp antibodies * 30 specimens must exhibit low to moderate dye loading for the Rh123 efflux assay * 10 specimens must exhibit positive Rh123 efflux activities 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

MeSH Terms

Conditions

LeukemiaLeukemia, Monocytic, AcuteLeukemia, Megakaryoblastic, AcuteLeukemia, Myeloid, AcuteLeukemia, Myelomonocytic, AcuteCongenital AbnormalitiesLeukemia, Erythroblastic, Acute

Interventions

Flow Cytometry

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, MyeloidCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMyeloproliferative DisordersBone Marrow Diseases

Intervention Hierarchy (Ancestors)

Cell SeparationCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisCytophotometryFluorometryLuminescent MeasurementsPhotometryChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Elisabeth Paietta, PhD

    Our Lady of Mercy Medical Center

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

March 28, 2006

Primary Completion

December 30, 2013

Study Completion

December 30, 2013

Last Updated

May 19, 2017

Record last verified: 2017-05