NCT02268643

Brief Summary

In the present study, the investigators will screen breast cancer of the Chinese women based on ultrasound and aim to compare the risk evaluation model of PUMCH model which was established by our previous work with other risk models.

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
20,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
1 country

16 active sites

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

January 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2014

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 20, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

October 20, 2014

Status Verified

October 1, 2014

Enrollment Period

2.9 years

First QC Date

September 29, 2014

Last Update Submit

October 15, 2014

Conditions

Keywords

breast cancerscreeningultrasoundrisk model

Outcome Measures

Primary Outcomes (1)

  • number of cancer detected in the high-risk group

    3 years

Study Arms (1)

group 1

ultrasound plus clinical breast examination

Other: ultrasound plus clinical breast examination

Interventions

all the participants will be required to fill risk factor questionaires and then be screened with ultrasound plus physical examination every year

group 1

Eligibility Criteria

Age35 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

healthy women without breast-related symptoms

You may qualify if:

  • Written informed consent;
  • residence from community or working units

You may not qualify if:

  • pregnancy;
  • lactation;
  • known metastatic cancer;
  • signs or symptoms of breast disease;
  • presence of breast implants, breast surgery within prior 12 months;
  • had mammography or ultrasound exam within prior 12 months
  • males.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Beijing ChaoYang Hospital affiliated to the Capital Medical University

Beijing, Beijing Municipality, China

RECRUITING

Beijing Hospital affiliated to Ministry of Health

Beijing, Beijing Municipality, China

RECRUITING

First Hospital affiliated to Peking University

Beijing, Beijing Municipality, China

RECRUITING

Southwest Hospital affiliated to the Third Military Medical University

Chongqing, Chongqing Municipality, China

RECRUITING

ShanXi Traditional Medicine Hospital

Taiyuan, Shanxi, China

RECRUITING

The Cancer Hospital affiliated to Tianjin Medical University

Tianjin, Tianjin Municipality, China

RECRUITING

Chifeng Baoshan Hospital

Chifeng, China

RECRUITING

First Affiliated Hospital of Chongqing Medical University

Chongqing, China

RECRUITING

First People's Hospital of Honghe State

Mengzi, China

RECRUITING

Ordos Central Hospital

Ordos, China

RECRUITING

Qingdao Municipal Hospital

Qingdao, China

RECRUITING

First Affiliated Hospital of China Medical University

Shenyang, China

RECRUITING

Hospital of Xinjiang Production and Construction Corps

Ürümqi, China

RECRUITING

Third Hospital of Xingtai

Xingtai, China

RECRUITING

Yingshan Maternal and Child Health Hospital

Yingshan, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Sun Qiang, MD

    PUMCH

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

September 29, 2014

First Posted

October 20, 2014

Study Start

January 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2017

Last Updated

October 20, 2014

Record last verified: 2014-10

Locations