DNA Analysis of Tumor Tissue From Patients With Acute Myeloid Leukemia

Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00897936
• Other study ID #: CDR0000476571
• Secondary ID: ECOG-E1900T2
• Status: Completed
• Start date: March 23, 2006
• Est. completion date: October 15, 2009

Study information

• Verified date: July 2020
• Source: Eastern Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 418
• Est. completion date: October 15, 2009
• Est. primary completion date: October 15, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosis of acute myeloid leukemia

• Enrolled on clinical trial ECOG-E1900

PATIENT CHARACTERISTICS:

• Not specified

PRIOR CONCURRENT THERAPY:

• Not specified

Related Conditions & MeSH terms

• Leukemia

Intervention

Genetic:
• DNA methylation analysis

• comparative genomic hybridization

• fluorescence in situ hybridization

• microarray analysis

• polymerase chain reaction

Other:
• diagnostic laboratory biomarker analysis

• immunologic technique

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
ECOG-ACRIN Cancer Research Group	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nucleophosmin exon 12 mutation-related normal cytogenetics leukemia (NCL) has a specific genetic and epigenetic profile		1 day
Primary	Relatedness on a per-gene basis of cross-platform data		1 day
Primary	Ability of supervised clustering to distinguish subgroups according to clinical prognostic and biomarker indicators		1 day
Primary	Ability of unsupervised clustering to identify subgroups of NCL patients		1 day
Primary	Relative power of each platform mentioned above vs the integrated platforms		1 day