跳至主要内容
临床试验/NCT04076111
NCT04076111尚未招募不适用

Patterns of Breast Cancer Management and Prognosis of Breast Cancer in China:a Multicenter, Prospective, Real-world Cohort Study

Fengxi Su5 个研究点 分布在 1 个国家目标入组 20,000 人开始时间: 2019年9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
20,000
试验地点
5
主要终点
Breast-conserving surgery rate,

研究概览

简要总结

This is a multicenter, prospective, e, real-world cohort survey initiated by researchers to focus on the patterns of breast cancer management and prognosis of breast cancer in China, and to establish the multicenter, prospective breast cancer data platform. A total of 18 sites in Guangdong and Henan have cooperated to build a cooperative network unit. The sites will conduct prospective and standardized records concerning the clinical pathological features, treatment and prognosis of the early breast cancer patients who are treated in their own site each year, registering in the REDCap system.This real-world cohort study aims to provide a representative and reliable survey data of epidemiological characteristics, clinical treatment and prognosis of patients with early breast cancer in China and explore the establishment of a national multi-center breast cancer data platform model.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients who are hospitalized and treated in a collaborative network unit
  • Agree to enroll in the study and sign the informed consent form
  • Histological diagnosis of ductal carcinoma in situ or invasive breast cancer
  • Accept the Surgery-based surgical treatment
  • Willing to cooperate with follow-up work

排除标准

  • Previously Excisional biopsy (including minimally invasive resection) of the patient's breast
  • Previously received neoadjuvant chemotherapy
  • Imaging or histological evidence of distant metastasis

结局指标

主要结局

Breast-conserving surgery rate,

时间窗: baseline

the proportion between breast-conserving surgery and breast mastectomy surgery baseline

Breast-conserving surgery rate, sentinel lymph node biopsy rate

时间窗: baseline

the proportion between sentinel lymph node biopsy and axillary lymph node dissection

次要结局

  • Disease free survival (DFS)(5year)
  • Overall survival (OS)(5year)
  • Epidemiological distribution of pathological stage of breast cancer(baseline)

研究者

发起方
Fengxi Su
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Fengxi Su

PI

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

研究点 (5)

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