NCT04440683

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

June 14, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 22, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

June 22, 2020

Status Verified

June 1, 2020

Enrollment Period

1.9 years

First QC Date

June 14, 2020

Last Update Submit

June 18, 2020

Conditions

Breast Cancer Prevention

Outcome Measures

Primary Outcomes (1)

  • Canceration by biopsy

    Imaging suspected malignant, confirmed by pathology

    1 year

Study Arms (1)

Antler plate group

Antler plate group

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients need to have good compliance

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Hospital of Jilin University

Changchun, Jilin, 130021, China

RECRUITING

Study Officials

  • Aiping Shi, Doctor

    The First Hospital of Jilin University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Di Wu, Doctor

CONTACT

0086-13504331975w2000mail@sohu.com

Hongyao Jia, Master

CONTACT

0086-158043015652272435@qq.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

June 14, 2020

First Posted

June 22, 2020

Study Start

June 1, 2020

Primary Completion

May 1, 2022

Study Completion

June 1, 2025

Last Updated

June 22, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)