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临床试验/NCT04440683
NCT04440683招募中不适用

Antler Plate on Preventing Mammary High-risk Lesions From Malignant Development

Jilin University1 个研究点 分布在 1 个国家目标入组 6,000 人开始时间: 2020年6月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
6,000
试验地点
1
主要终点
Canceration by biopsy

研究概览

简要总结

This study aims to prove whether antler disk extract can be put into clinical practice to prevent breast precancerous lesions from developing into cancer.

详细描述

Through estrogen receptor antagonists, tamoxifen can reduce the risk of breast high-risk disease progression to cancer, but only reduce the probability of some ER and PR positive tumors, which has no preventive effect on triple negative breast cancer and HER-2 positive breast cancer. In the first hospital of Jilin University, the preparations containing antler ingredients have been clinically proven to be able to treat breast hyperplasia, which has been proved to be able to prevent breast cancer in basic research, and antler ingredients have been proved to be non-toxic and side effects in the treatment dose. This study aims to prove whether antler disk extract can be put into clinical practice to prevent breast precancerous lesions from developing into 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
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women between the ages of 18 and 80
  • Atypical hyperplasia or / and lobular carcinoma in situ confirmed by breast histology
  • Women with breast cancer in first degree relatives
  • Patients have better compliance with a series of research-related behaviors such as the upcoming comprehensive treatment and follow-up, and can understand and accept the research process of this study, and sign a written informed consent

排除标准

  • Hepatorenal dysfunction, cardiovascular and cerebrovascular diseases
  • Patients not suitable for this study judged by researchers

结局指标

主要结局

Canceration by biopsy

时间窗: 1 year

Imaging suspected malignant, confirmed by pathology

次要结局

未报告次要终点

研究者

发起方
Jilin University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Aiping Shi

professor

Jilin University

研究点 (1)

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