NCT06566729进行中（未招募）不适用
Application of Molecular Residual Disease in the Recurrence Monitoring and Response Predicting of High-risk Early Breast Cancer
Shanghai Jiao Tong University School of Medicine0 个研究点目标入组 125 人开始时间: 2023年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 125
- 主要终点
- Relapse-free survival
研究概览
简要总结
This study is a multicenter, prospective, observational cohort study, 125 patients with early-stage high-risk breast cancer will be enrolled, perioperative surgical specimens, peripheral blood specimens before and after adjuvant therapy and follow-up will be collected, and the predictive effect of MRD of molecular residual lesions on recurrence events and drug efficacy will be evaluated through dynamic monitoring, so as to further accurately stratify the risk and guide clinical intervention.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Informed consent signed
- •Age ≥18 years old
- •Undergoing breast surgery, the surgical specimen was diagnosed as invasive breast cancer by the central laboratory and met any of the following conditions:
- •Hormone receptor-positive/HER2-negative breast cancer, the number of lymph node metastases ≥ 4;
- •HER2-positive breast cancer, lymph node metastasis≥4;
- •Triple negative breast cancer, the number of lymph node metastases ≥ 1;
- •Willing to cooperate in clinical research-related treatment and follow-up, with good patient compliance
排除标准
- •Confirmed distant metastases site
- •History of other malignancy
- •Psychopaths or other reasons unable to comply with treatment
- •Concomitant uncontrolled lung disease, severe liver and kidney disease, severe infection, active peptic ulcer requiring treatment, coagulation disorders, connective tissue disease, or bone marrow suppression, and cannot tolerate chemotherapy and other related treatments
- •HIV carrier or HBC/HCV infected
- •Current or recent (within 30 days prior to enrollment) use of participation in another investigational program or use of another investigational drug
结局指标
主要结局
Relapse-free survival
时间窗: 5 years after surgery
Defined as the time from the diagnosis of the disease to the first occurrence of a local recurrence of breast cancer, distant recurrence, or death from any cause
次要结局
- Overall survival(5 years after surgery)
- Lead time(2 years after surgery)
研究者
Kunwei Shen
Professor
Ruijin Hospital
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