A Pilot Study to Characterize the Genomic and Epigenomic Signature of NPM Positive Vs. NPM Negative NCL
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- ECOG-ACRIN Cancer Research Group
- Enrollment
- 418
- Primary Endpoint
- Relatedness on a per-gene basis of cross-platform data
Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 120 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Relatedness on a per-gene basis of cross-platform data
Time Frame: 1 day
Nucleophosmin exon 12 mutation-related normal cytogenetics leukemia (NCL) has a specific genetic and epigenetic profile
Time Frame: 1 day
Ability of supervised clustering to distinguish subgroups according to clinical prognostic and biomarker indicators
Time Frame: 1 day
Ability of unsupervised clustering to identify subgroups of NCL patients
Time Frame: 1 day
Relative power of each platform mentioned above vs the integrated platforms
Time Frame: 1 day
Secondary Outcomes
No secondary outcomes reported