NCT01419496

Brief Summary

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about cancer and development of drug resistance in patients. PURPOSE: This research trial is studying proteins that may promote chemotherapy resistance in 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

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

First Submitted

Initial submission to the registry

August 17, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 18, 2011

Completed
14 days until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Last Updated

May 18, 2016

Status Verified

May 1, 2016

Enrollment Period

4.7 years

First QC Date

August 17, 2011

Last Update Submit

May 17, 2016

Conditions

Leukemia

Keywords

recurrent adult acute myeloid leukemiarecurrent childhood acute myeloid leukemiaadult acute myeloid leukemia with 11q23 (MLL) abnormalitiesadult 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)adult acute myeloid leukemia with del(5q)

Outcome Measures

Primary Outcomes (2)

  • Changes in Stat3 and Stat5 in paired diagnostic and relapsed AML samples

  • Reduction in chemotherapy sensitivity by relapsed samples compared to diagnostic samples

Interventions

protein expression analysisGENETIC
flow cytometryOTHER
laboratory biomarker analysisOTHER

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: * Paired diagnostic and relapsed cryopreserved samples from patients with acute myeloid leukemia 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, Myeloid, AcuteCongenital Abnormalities

Interventions

Flow Cytometry

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, MyeloidCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Michele S. Redell, MD, PhD

    Texas Children's 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

August 17, 2011

First Posted

August 18, 2011

Study Start

September 1, 2011

Primary Completion

May 1, 2016

Last Updated

May 18, 2016

Record last verified: 2016-05