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临床试验/NCT00904566
NCT00904566已完成不适用

Validation 70-gene MammaPrint Profile in Japanese Population

Agendia1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2008年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Agendia
入组人数
102
试验地点
1
主要终点
The probability of recurrence free survival (PRFS)

研究概览

简要总结

By using gene-expression profiling, Van't Veer and colleagues developed a 70-gene prognosis profile, MammaPrint, to identify breast cancer patients who are at low risk of developing distant metastases and therefore might safely be spared chemotherapy. The aim of this study is to evaluate the prognostic value of the 70-gene Mammaprint profile in Japanese women with node-negative breast cancer.

详细描述

Frozen tumor samples from 140 node-negative, breast cancer patients aged between 29 and 70 years at diagnosis are hybridized on MammaPrint array. Patients were treated with breast conserving therapy or mastectomy with axillary lymph node dissection between December 1998 and August 2001 at Osaka Medical Center for Cancer and Cardiovascular Diseases. Samples are evaluated by gene expression profiling for the 70-gene MammaPrint profile and classified as genomic high risk or genomic low risk.

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
29 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Breast cancer patients
  • Node-negative
  • Treated with breast conserving therapy or mastectomy with axillary lymph node dissection at Osaka Medical Center for Cancer and Cardiovascular Diseases

排除标准

  • 未提供

结局指标

主要结局

The probability of recurrence free survival (PRFS)

时间窗: 5 years

次要结局

未报告次要终点

研究者

发起方
Agendia
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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