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临床试验/NCT00897936
NCT00897936已完成不适用

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

ECOG-ACRIN Cancer Research Group0 个研究点目标入组 418 人开始时间: 2006年3月23日最近更新:
适应症

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

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

研究者

发起方
ECOG-ACRIN Cancer Research Group
申办方类型
Network
责任方
Sponsor

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