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临床试验/NCT06027541
NCT06027541进行中(未招募)不适用

Prospective Research of Young Patients With Early Breast Cancer

Peking Union Medical College Hospital1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2023年8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)
入组人数
1,000
试验地点
1
主要终点
5-year disease free survival (DFS)

研究概览

简要总结

The prognosis of young patients with breast cancer is relatively poor. Chemotherapy damages ovarian function. Endocrine treatment for up to 10 years delays the childbearing time of patients. Treatment regimens in young breast cancer patients are still controversial in the following: 1. Exemption from chemotherapy based on gene prediction results; 2. Removing drugs that damage ovarian function from chemotherapy regimens; 3. Giving ovarian protection drugs during chemotherapy for patients with hormone receptor (HR)+; 4. The right time to get pregnant. In view of the above problems, the treatment scheme recommended in the guidelines cannot meet the personalized needs of young breast cancer patients. The project plans to establish a prognosis model for young patients with breast cancer, and provide the patients hierarchical and refined management, which is significant for prolonging survival time, improving quality of life, and protecting fertility. This project plans to observe the relationship between the characteristics of immune genes, pathological staging, molecular typing, treatment plans and prognosis in the cohort of young breast cancer patients, and establish a young breast cancer prognosis model and verify it. The project is expected to establish a prognosis model and provide a hierarchical and personalized precision treatment plan for young breast cancer patients, so as to prolong the survival time, improve the fertility rate, and improve the quality of life.

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
— 至 40 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • patients with breast cancer received operation in Peking Union Medical College Hospital
  • age ≤40 year old and ≥20 years old
  • treatment regimen was made in Peking Union Medical College Hospital

排除标准

  • patients without pathological information
  • patients with metastasis
  • patients with history of other malignant tumor (except for completely cured cervical carcinoma in situ or basal cell carcinoma or squamous cell skin carcinoma)
  • patients with palliative resection of breast

结局指标

主要结局

5-year disease free survival (DFS)

时间窗: 5 year

DFS: From the time of surgery to the time of recurrence or metastasis, calculated on a monthly basis, until the most recent discovery of recurrence or metastasis.

次要结局

  • the correlation between poor characteristics and survival(5-year)
  • 5-year recurrence(5-year)
  • 5-year metastasis(5-year)
  • 5-year overall survival (OS)(5-year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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