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

NCT ID: NCT04440683

Last Updated: 2020-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

6000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-30

Study Completion Date

2025-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Breast Cancer Prevention

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Antler plate group

Antler plate group

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Jilin University

OTHER

Sponsor Role lead

Responsible Party

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Aiping Shi

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aiping Shi, Doctor

Role: PRINCIPAL_INVESTIGATOR

The First Hospital of Jilin University

Locations

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First Hospital of Jilin University

Changchun, Jilin, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Di Wu, Doctor

Role: CONTACT

0086-13504331975

Hongyao Jia, Master

Role: CONTACT

0086-1580430156

Facility Contacts

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Aiping Shi, Doctor

Role: primary

0086-13364308696

Zhimin Fan, Doctor

Role: backup

0086-13756661286

Other Identifiers

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20190701041GH

Identifier Type: -

Identifier Source: org_study_id

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