Ultrasound and Mammography for Screening Breast Cancer in Chinese Women

NCT ID: NCT01880853

Last Updated: 2013-09-10

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

COMPLETED

Clinical Phase

NA

Total Enrollment

47709 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2011-12-31

Brief Summary

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Early detection of breast cancer through screening has been a common practice in the United States and several European countries for decades.It is effective in reducing the mortality of breast cancer and improving the postoperative quality of life of patients. Mammography has been the standard imaging method for the screening, and in recent years, a supplemental ultrasound exam is also recommended.A prospective, multi-center, randomized trial is needed to define an optimal screening strategy that suits Chinese women and the socioeconomics of China.

Detailed Description

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Conditions

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Breast Cancer

Keywords

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breast cancer screening mammography ultrasound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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group 1

screening with mammography alone

Group Type EXPERIMENTAL

mammography

Intervention Type OTHER

participants were screened by mammography alone every year

group 2

screening with ultrasonography alone

Group Type EXPERIMENTAL

ultrasound

Intervention Type OTHER

participants were screened by ultrasound alone every year

group 3

screening with both mammography and ultrasound

Group Type EXPERIMENTAL

mammography and ultrasound

Intervention Type OTHER

Participants were screened by both mammography and ultrasound every year

Interventions

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mammography

participants were screened by mammography alone every year

Intervention Type OTHER

ultrasound

participants were screened by ultrasound alone every year

Intervention Type OTHER

mammography and ultrasound

Participants were screened by both mammography and ultrasound every year

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sun Qiang, MD

Role: STUDY_CHAIR

PUMCH

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status

Beijing ChaoYang Hospital affiliated to the Capital Medical University

Beijing, Beijing Municipality, China

Site Status

Beijing Hospital affiliated to Ministry of Health

Beijing, Beijing Municipality, China

Site Status

Chinese 307 Hospital affiliated to the People's Liberation Army

Beijing, Beijing Municipality, China

Site Status

First Hospital affiliated to Peking University

Beijing, Beijing Municipality, China

Site Status

The Cancer Institute & Hospital, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status

The General Hospital affiliated to Beijing Military Area Command

Beijing, Beijing Municipality, China

Site Status

Southwest Hospital affiliated to the Third Military Medical University

Chongqing, Chongqing Municipality, China

Site Status

Population and Family Planning Service Center of Zhuhai

Zhuhai, Guangdong, China

Site Status

Maternity & Child Care Center of Qinhangdao

Qinhuangdao, Hebei, China

Site Status

YingBin Surgery Hospital of Yancheng

Yancheng, Jiangsu, China

Site Status

The Cancer Hospital affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Site Status

ShanXi Traditional Medicine Hospital

Taiyuan, Shanxi, China

Site Status

The Cancer Hospital affiliated to Tianjin Medical University

Tianjin, Tianjin Municipality, China

Site Status

Countries

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China

References

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Shen S, Zhou Y, Xu Y, Zhang B, Duan X, Huang R, Li B, Shi Y, Shao Z, Liao H, Jiang J, Shen N, Zhang J, Yu C, Jiang H, Li S, Han S, Ma J, Sun Q. A multi-centre randomised trial comparing ultrasound vs mammography for screening breast cancer in high-risk Chinese women. Br J Cancer. 2015 Mar 17;112(6):998-1004. doi: 10.1038/bjc.2015.33.

Reference Type DERIVED
PMID: 25668012 (View on PubMed)

Other Identifiers

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PUMCH-breast-screening

Identifier Type: -

Identifier Source: org_study_id