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临床试验/NCT01589341
NCT01589341已完成不适用

Prognostic Impact of Segmental Chromosome Aberrations in Non MYCN Amplified Neuroblastomas in Different Age Groups

Children's Oncology Group1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2012年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
300
试验地点
1
主要终点
Overall survival (OS)

研究概览

简要总结

This research studies chromosomes in samples from younger patients with neuroblastoma. Studying samples of tumor 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.

详细描述

OBJECTIVES:

I. Determine the impact on overall survival of patients with non-MYCN neuroblastoma below 18 months of age as compared to neuroblastoma patients above 18 months of age.

OUTLINE:

Archived DNA samples are analyzed for segmental chromosome aberrations by multiplex ligation-dependent probe amplification (MLPA), a polymerase chain reaction (PCR)-based technique. The following genomic regions are being studied: 1p, 1q, 3p, 4p, 7q, 9p, 11q, and 17q, as are the copy numbers of MYCN, NAG, DDX1, and ALK genes.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Samples from neuroblastoma patients who, according to risk stratification, did not receive cytotoxic treatment and did never receive chemotherapy and are in complete response (CR) OR patients who, according to risk stratification, did not receive cytotoxic treatment initially, but had a localized or a systemic (stage Ms or M) relapse with or without following chemotherapy
  • Low-risk Children Oncology Group (COG) designation: no initial cytotoxic treatment, any stage, any age, any outcome
  • DNA from untreated neuroblastoma tumor samples (from patients in the age group below and from patients in the age group above 1.5 years of age) available from the COG, Europe, Israel, and Japan
  • No MYCN amplification
  • No Schwann cell stroma-rich tumors
  • No tumor cell content below 60%
  • No patients diagnosed before 1997 and after 2005
  • No lack of follow-up data
  • See Disease Characteristics
  • No initial cytotoxic treatment

排除标准

  • 未提供

结局指标

主要结局

Overall survival (OS)

时间窗: From the date of diagnosis to the date of death from any cause, assessed up to 5 years

Estimated by the Kaplan-Meier method.

次要结局

  • Incidence of metastatic relapses using cumulative incidences(Up to 5 years)
  • Event-free survival (EFS)(From the date of diagnosis to the date of disease progression, death from any cause, or secondary neoplasm, assessed up to 5 years)

研究者

申办方类型
Network
责任方
Sponsor

研究点 (1)

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