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临床试验/NCT04344496
NCT04344496招募中不适用

The Cancer Genome Atlas and Recurrence Risk Prediction of East Asian Breast Cancer: a Multicenter Collaborative Study

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2018年10月18日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
2,000
试验地点
1
主要终点
Prevalence of unique genetic alterations

研究概览

简要总结

This project aims to establish the cancer genome atlas and the platform of recurrence risk prediction specific for East Asian breast cancer patients. The study was planned to collect blood sample, fresh tumor tissue, and paraffin embedded tumor tissue from 2000 patients. Aims to identify unique genetic alterations in Asian tumors, to identify the susceptible genes for breast carcinogenesis in East Asia, and to establish the new platform for accurate prediction of recurrence. The investigator will explore the association of patient outcomes with the genetic alterations from the cancer atlas of East Asian breast tumors.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • Aged more than 20-year-old at the time of informed consent.
  • An unconfirmed breast tumor, or have histologically confirmed invasive breast cancer.
  • Have radiological or objective evidence of breast tumor size ≥1 cm.
  • Be able to comply with study procedures to collect the clinical medical information, blood sample, fresh tumor tissue, and 12 sections of paraffin embedded tumor tissue.
  • Be able to sign an informed consent.

排除标准

  • Have histologically confirmed ductal carcinoma in situ (DCIS).
  • Stage I, II or III breast cancer patients who have received neoadjuvant treatments, including chemotherapy, hormonal therapy, or targeted therapy.
  • Stage IV or metastatic breast cancer patients who have received chemotherapy.

结局指标

主要结局

Prevalence of unique genetic alterations

时间窗: 3 years

To establish the cancer genome atlas and identify the susceptible genes for breast carcinogenesis in East Asia

次要结局

  • Recurrence rate(10 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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