NCT00897936

Brief Summary

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how well patients respond to treatment. PURPOSE: This laboratory study is looking at 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
418

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2006

Typical duration 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 23, 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
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2009

Completed
Last Updated

July 31, 2020

Status Verified

July 1, 2020

Enrollment Period

3.6 years

First QC Date

May 9, 2009

Last Update Submit

July 29, 2020

Conditions

Leukemia

Keywords

adult acute myeloid leukemia in remissionrecurrent adult acute myeloid leukemiauntreated adult 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)

Outcome Measures

Primary Outcomes (5)

  • Nucleophosmin exon 12 mutation-related normal cytogenetics leukemia (NCL) has a specific genetic and epigenetic profile

    1 day

  • Relatedness on a per-gene basis of cross-platform data

    1 day

  • Ability of supervised clustering to distinguish subgroups according to clinical prognostic and biomarker indicators

    1 day

  • Ability of unsupervised clustering to identify subgroups of NCL patients

    1 day

  • Relative power of each platform mentioned above vs the integrated platforms

    1 day

Interventions

DNA methylation analysisGENETIC
comparative genomic hybridizationGENETIC
fluorescence in situ hybridizationGENETIC
microarray analysisGENETIC
polymerase chain reactionGENETIC
diagnostic laboratory biomarker analysisOTHER
immunologic techniqueOTHER

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of acute myeloid leukemia * Enrolled on clinical trial ECOG-E1900 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

DNA MethylationComparative Genomic HybridizationIn Situ Hybridization, FluorescenceMicroarray AnalysisPolymerase Chain ReactionImmunologic Techniques

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

MethylationAlkylationBiochemical PhenomenaChemical PhenomenaMetabolismGenetic PhenomenaCytogenetic AnalysisGenetic TechniquesInvestigative TechniquesMolecular Diagnostic TechniquesNucleic Acid HybridizationIn Situ HybridizationStaining and LabelingHistocytological Preparation TechniquesCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesMicrochip Analytical ProceduresNucleic Acid Amplification Techniques

Study Officials

  • Ari M. Melnick, MD

    Albert Einstein College of Medicine

    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 23, 2006

Primary Completion

October 15, 2009

Study Completion

October 15, 2009

Last Updated

July 31, 2020

Record last verified: 2020-07