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

June 18, 2020 updated by: Aiping Shi, Jilin University
This study aims to prove whether antler disk extract can be put into clinical practice to prevent breast precancerous lesions from developing into cancer.

Study Overview

Status

Recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

6000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Hongyao Jia, Master
  • Phone Number: 0086-1580430156
  • Email: 52272435@qq.com

Study Locations

  • China
    • Jilin
      • Changchun, Jilin, China, 130021
        • Recruiting
        • First Hospital of Jilin University
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Di Wu, Doctor
        • Sub-Investigator:
          • Hongyao Jia, Master
        • Sub-Investigator:
          • Xin Guan, Master
        • Principal Investigator:
          • Zhimin Fan, Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients need to have good compliance

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Antler plate group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Canceration by biopsy
Time Frame: 1 year
Imaging suspected malignant, confirmed by pathology
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jilin University

Investigators

  • Principal Investigator: Aiping Shi, Doctor, The First Hospital of Jilin University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2020

Primary Completion (Anticipated)

May 1, 2022

Study Completion (Anticipated)

June 1, 2025

Study Registration Dates

First Submitted

June 14, 2020

First Submitted That Met QC Criteria

June 18, 2020

First Posted (Actual)

June 22, 2020

Study Record Updates

Last Update Posted (Actual)

June 22, 2020

Last Update Submitted That Met QC Criteria

June 18, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 20190701041GH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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