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临床试验/NCT00958659
NCT00958659
已完成
不适用

Prognostic Multigene Expression Classification of Neuroblastoma Patients

Children's Oncology Group1 个研究点 分布在 1 个国家目标入组 350 人2008年12月

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Localized Resectable Neuroblastoma
发起方
Children's Oncology Group
入组人数
350
试验地点
1
主要终点
mRNA expression levels from genes that have been shown (in at least two independent studies) to have power for outcome prediction in children with NB, assessed by real-time PCR
状态
已完成
最后更新
9年前

概览

简要总结

This research trial studies specimens from young patients with neuroblastoma. Studying the genes expressed in specimens from patients with cancer may help doctors identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

详细描述

PRIMARY OBJECTIVES: I. Establish a robust messenger ribonucleic acid (mRNA) gene expression classifier for improved outcome prediction in children with neuroblastoma by using real-time polymerase chain reaction (PCR) to quantify mRNA levels from genes that have been shown in at least 2 independent studies to have predictive power. II. Identify microRNA (miRNA) patterns that have prognostic significance in neuroblastoma (NB) as accumulating evidence indicates that alterations in miRNA expression play a critical role in tumorigenesis and can be used in prognostic evaluation. III. To perform an integrated analysis of the established microRNA classifier with our mRNA signature to determine whether it results in even better classification of NB tumors. OUTLINE: Previously collected samples are analyzed for 59 prognostic genes by real-time quantitative PCR-based gene expression profiling.

注册库
clinicaltrials.gov
开始日期
2008年12月
结束日期
2016年5月
最后更新
9年前
研究类型
Observational
性别
All

研究者

责任方
Sponsor

入排标准

入选标准

  • Diagnosis of primary Neuroblastoma
  • Untreated disease
  • RNA samples from primary untreated NB-tumors available in Children's Oncology Group (COG) repository
  • At least 60% tumor cells
  • At least 2 years of follow-up from the date of diagnosis
  • Full clinical and biological annotation

排除标准

  • 未提供

结局指标

主要结局

mRNA expression levels from genes that have been shown (in at least two independent studies) to have power for outcome prediction in children with NB, assessed by real-time PCR

时间窗: Baseline

Multivariate logistic regression analyses will be performed to determine if the mRNA expression signature is a significant independent predictor after controlling for currently used risk factors.

miRNA patterns that have prognostic significance in NB, assessed by a reverse transcription quantitative PCR-based 'stem-loop' method to quantify expression levels

时间窗: Baseline

Multivariate logistic regression analyses will be performed to determine if the miRNA expression signature is a significant independent predictor after controlling for currently used risk factors.

研究点 (1)

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