NCT00898092

Brief Summary

RATIONALE: Collecting and storing samples of tissue and blood from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer. PURPOSE: This laboratory study is looking at changes in the DNA of tissue samples that were collected from patients with acute myeloid leukemia.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
735

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

May 1, 2006

Completed
3 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
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Last Updated

August 17, 2021

Status Verified

August 1, 2021

Enrollment Period

6.6 years

First QC Date

May 9, 2009

Last Update Submit

August 16, 2021

Conditions

Leukemia

Keywords

adult acute minimally differentiated myeloid leukemia (M0)adult acute myeloblastic leukemia without maturation (M1)adult acute myeloblastic leukemia with maturation (M2)adult acute myelomonocytic leukemia (M4)adult acute monoblastic leukemia (M5a)adult acute monocytic leukemia (M5b)adult erythroleukemia (M6a)adult pure erythroid leukemia (M6b)adult acute megakaryoblastic leukemia (M7)adult acute eosinophilic leukemiaadult acute basophilic leukemiauntreated adult acute myeloid leukemia

Outcome Measures

Primary Outcomes (3)

  • Prognostic stratification of patients through BAALC and ERG overexpression and microarray gene-expression signatures

    Baseline

  • Differential microRNA expression

    Baseline

  • Relative contribution of genetic markers in predicting clinical outcome

    Baseline

Study Arms (1)

Group 1

Peripheral blood and bone marrow samples are analyzed to assess gene expression using polymerase chain reaction (PCR) or reverse transcriptase-PCR assays and microarray assays. Genes to be studied include BAALC, ERB, EVI1, MLL, FLT3, NPM1, and CEBPA.

Genetic: microarray analysisGenetic: molecular genetic techniqueGenetic: mutation analysisGenetic: polymerase chain reactionGenetic: reverse transcriptase-polymerase chain reactionOther: diagnostic laboratory biomarker analysis

Interventions

microarray analysisGENETIC
Group 1
molecular genetic techniqueGENETIC
Group 1
mutation analysisGENETIC
Group 1
polymerase chain reactionGENETIC
Group 1
reverse transcriptase-polymerase chain reactionGENETIC
Group 1
diagnostic laboratory biomarker analysisOTHER
Group 1

Eligibility Criteria

Age15 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients enrolled on CALGB 19808 with tissue previously submitted to the CALGB Leukemia Tissue Bank

DISEASE CHARACTERISTICS: * Diagnosis of acute myeloid leukemia * Normal karyotype * Bone marrow and/or peripheral blood samples from patients treated on CALGB-19808 and registered on CALGB-9665 required * No additional samples required

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210-1240, United States

Location

MeSH Terms

Conditions

LeukemiaLeukemia, Myeloid, AcuteLeukemia, Myelomonocytic, AcuteLeukemia, Monocytic, AcuteLeukemia, Erythroblastic, AcuteLeukemia, Megakaryoblastic, AcuteLeukemia, Eosinophilic, AcuteLeukemia, Basophilic, Acute

Interventions

Microarray AnalysisGenetic TestingPolymerase Chain ReactionReverse Transcriptase Polymerase Chain Reaction

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, MyeloidMyeloproliferative DisordersBone Marrow Diseases

Intervention Hierarchy (Ancestors)

Microchip Analytical ProceduresInvestigative TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisGenetic TechniquesGenetic ServicesHealth ServicesHealth Care Facilities Workforce and ServicesDiagnostic ServicesPreventive Health ServicesNucleic Acid Amplification Techniques

Study Officials

  • Guido Marcucci, MD

    Ohio State University Comprehensive Cancer Center

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

May 1, 2006

Primary Completion

December 1, 2012

Last Updated

August 17, 2021

Record last verified: 2021-08

Locations

US(1)