NCT05901025尚未招募不适用
Homologous Recombination Repair Pathway Gene Mutation Spectrum in Chinese Breast Cancer Patients: A Multi-center, Prospective, Observational Study
Shanghai Jiao Tong University School of Medicine0 个研究点目标入组 5,000 人开始时间: 2023年6月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 5,000
- 主要终点
- Homologous recombination repair pathway gene mutation spectrum
研究概览
简要总结
The goal of this clinical trial is to learn about the mutation spectrum of homologous recombination repair pathway genes and its instructive significance in the treatment of Chinese breast cancer patients.
详细描述
The main questions it aims to answer are:
- What is the mutation spectrum of homologous recombination repair pathway genes in Chinese breast cancer patients?
- Does homologous recombination repair pathway gene mutation have an impact on patient outcome (breast cancer recurrence, neoadjuvant chemotherapy efficacy, treatment decisions, etc.) ? There is no intervention on participants, but all participants will be given regular follow-up post surgery according to ASCO guidelines.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathology-confirmed breast cancer patients who meet at least one of the criteria below:
- •Triple-negative breast cancer
- •Age ≤ 50 years
- •Male breast cancer
- •With personal or family history of malignancy: breast cancer, ovarian cancer, prostate cancer, pancreatic cancer, other malignancies
- •HER-2 negative recurrent or metastatic breast cancer
- •HER-2 negative high-risk breast cancer:
- •A: Neoadjuvant phase: non-pathological complete response for triple-negative breast cancer; non-pathological complete response AND CPS+EG score ≥ 3 for hormone receptor positive breast cancer B: Adjuvant phase: ≥ pT2 or ≥ pN1 for triple-negative breast cancer; ≥ 4 lymph node metastasis for hormone receptor positive breast cancer
- •Having been or intended to be tested for germline and (or) somatic homologous recombination repair gene mutations
- •Consent to providing medical charts and homologous recombination repair gene testing results, and being cooperative for long-term follow-up
排除标准
- •Homologous recombination repair gene testing results unavailable
- •Other factors deemed by the investigators that may sabotage the study
结局指标
主要结局
Homologous recombination repair pathway gene mutation spectrum
时间窗: At recruitment
to reveal the homologous recombination repair pathway gene mutation spectrum
次要结局
- Breast cancer events(At 5 years from surgery)
- Treatment decision and appliance(At 5 years from surgery)
研究者
Kunwei Shen
Professor, Director of Comprehensive Breast Health Center, Ruijin Hospital
Shanghai Jiao Tong University School of Medicine
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