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临床试验/NCT02669745
NCT02669745已完成不适用

The Study of Molecular Risk Panels in Chinese Breast Cancer Patient Using Mammaprint, TargetPrint, BluePrint and Research Gene Panel Assays.

Agendia1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2012年1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
64
试验地点
1
主要终点
Comparing MammaPrint with Clinical Risk Assessment

研究概览

简要总结

This study is experimental and will prospectively assess the proportion of patients in the two (2) MammaPrint Risk categories in patients of Chinese descent.

详细描述

The incidence of breast cancer in Chinese women is lower than that of a Western population. Breast cancer is the most common cancer in Chinese women and the incidence is rising. Moreover there are more premenopausal women with breast cancer where the breast cancer incidence peaks in the forties and the postmenopausal rise in incidence is less commonly seen. As the genetic predisposition to breast cancer is increasingly understood, it has been suggested that the differences in breast cancer incidence in different ethnic populations is potentially due to interactions between lifestyle and genetic characteristics. To date, the use of Agendia's gene expression assays in Chinese women has not been studied. In this study, the feasibility of the gene-expression prognostic assays for risk assessment in this specific group will be assessed. Moreover, the specific molecular characteristics and potential biomarkers will be studied, focusing especially on the large group of premenopausal breast cancer patients.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Females aged 18 year to 70 year,
  • diagnosis of Stage I or Stage II (excluding those involving more than 3 lymph nodes) Breast Cancer
  • Chinese descent

排除标准

  • Stage II Breast Cancer with more than 3 positive lymph nodes

结局指标

主要结局

Comparing MammaPrint with Clinical Risk Assessment

时间窗: 6 weeks

The MammaPrint risk assessment outcomes will be compared with conventionally used risk assessments determined by clinical parameters, standard staging and IHC analysis (Adjuvant! Online) in a population of Chinese patients with breast cancer.

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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