A Pilot Study to Characterize the Genomic and Epigenomic Signature of NPM Positive Vs. NPM Negative NCL
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 418
- 主要终点
- Relatedness on a per-gene basis of cross-platform data
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 120 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Relatedness on a per-gene basis of cross-platform data
时间窗: 1 day
Nucleophosmin exon 12 mutation-related normal cytogenetics leukemia (NCL) has a specific genetic and epigenetic profile
时间窗: 1 day
Ability of supervised clustering to distinguish subgroups according to clinical prognostic and biomarker indicators
时间窗: 1 day
Ability of unsupervised clustering to identify subgroups of NCL patients
时间窗: 1 day
Relative power of each platform mentioned above vs the integrated platforms
时间窗: 1 day
次要结局
未报告次要终点
