NCT04626440招募中不适用
Comprehensive Precision Medicine Research on the Heterogeneity of Taiwanese Breast Cancer Patients by Next Generation Sequencing (NGS) Tools
vghtpe user1 个研究点 分布在 1 个国家目标入组 1,875 人开始时间: 2018年11月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,875
- 试验地点
- 1
- 主要终点
- The rate of genomic alteration
研究概览
简要总结
The objectives of this study are:
- To determine the difference in genetic profiling of subjects with breast cancer recurrence
- To determine the comprehensive genetic profiling of subjects with late stage breast cancer
- To determine the potential biomarkers for early detection and prognosis for breast cancer
- To determine the genetic profiling of immune system in different subtypes of breast cancer
By integrating and analyzing the data generated using the methods of NGS, these information can be used for:
- Understanding the genetic profiling of different subtypes of breast cancer in Taiwan
- Assessing the efficacy of different treatments in breast cancer subjects
- Defining the molecular risk factors and predicting the potential risk of breast cancer recurrence
- Assessing the immune repertoire and the potential effects of immunotherapy in breast cancer subjects
- Developing new strategies in treating patients with triple negative or late stage of breast cancer
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female subjects aged over 20 years old
- •Subject with confirmed diagnosis of primary invasive breast cancer and is planning to receive treatments for breast cancer. However, subjects with breast cancer recurrence at screening will be enrolled if meet both the following conditions:
- •Subjects had received surgery for primary breast cancer within 3 years prior to screening [i.e. recurrence within 3 years after surgery (mastectomy or BCS)];
- •Subjects diagnosed with stage IV breast cancer beyond 3 years after surgery (mastectomy or BCS) or who had received or are currently receiving treatments for breast cancer. And subjects with primary tumor FFPE tissues available and pass the RNA quality check.
- •Eastern Cooperative Oncology Group (ECOG) Performance score ≤ 3
- •Life expectancy ≥ 3 months
- •Subject agrees to provide the written informed consent. If a subject has breast cancer recurrence within 3 years prior to screening, she will be eligible if she agrees to provide the paired FFPE tissues (primary and recurrent tumors)
排除标准
- •Subjects will be excluded if they had primary cancer other than breast cancer within 5 years prior to screening
结局指标
主要结局
The rate of genomic alteration
时间窗: Aug.2026
Discovery of comprehensive genetic profiles including copy number variation and single nucleotide polymorphism in group 1, 2 and 3 subjects. Discovery of genetic mutations of T cell receptor
Clinical outcome
时间窗: Aug.2026
Breast cancer recurrence, overall survival and recurrence-free survival
次要结局
未报告次要终点
研究者
vghtpe user
Chief of Comprehensive Breast Health Center, Department of Surgery
Taipei Veterans General Hospital, Taiwan
研究点 (1)
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