DNA Analysis of Tumor Tissue From Patients With Acute Myeloid Leukemia

A Pilot Study to Characterize the Genomic and Epigenomic Signature of NPM Positive Vs. NPM Negative NCL

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00897936

Enrollment

418

Registered

2009-05-12

Start date

2006-03-23

Completion date

2009-10-15

Last updated

2020-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia

Keywords

adult acute myeloid leukemia in remission, recurrent adult acute myeloid leukemia, untreated adult acute myeloid leukemia, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, 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)

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.

Detailed description

OBJECTIVES: Primary * Determine gene expression, genome integrity, cytosine methylation, and chromatin structure in patients with normal cytogenetics leukemia (NCL) acute myeloid leukemia. * Determine whether NCL can be deconstructed into specific disease entities by analysis of the integrated genomic and epigenomic datasets using supervised and unsupervised methods in these patients. * Identify the gene pathways that define NCL subtypes and molecular targets for validation in preclinical and clinical trials for these patients. * Determine whether integrated analysis provides markers of prognostic and therapeutic response that accurately predicts clinical outcome and can be used to select patients for risk-stratified therapeutic trials. OUTLINE: This is a pilot, multicenter study. Samples are analyzed to assess array comparative genomic hybridization using polymerase chain reaction (PCR) and fluorescent in situ hybridization; chromatin immunoprecipitations (chip) using PCR; Hpa II tiny fragment enrichment by ligation-mediated PCR (HELP) using DNA methylation analysis; and gene expression profiling. PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study.

Interventions

OTHERdiagnostic laboratory biomarker analysis

OTHERimmunologic technique

GENETICDNA methylation analysis

GENETICcomparative genomic hybridization

GENETICfluorescence in situ hybridization

GENETICmicroarray analysis

GENETICpolymerase chain reaction

Study design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 120 Years

Healthy volunteers

Inclusion criteria

DISEASE CHARACTERISTICS: * Diagnosis of acute myeloid leukemia * Enrolled on clinical trial ECOG-E1900 PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * Not specified

Design outcomes

Primary

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026