search
Back to results

Ultrasound and Mammography for Screening Breast Cancer in Chinese Women

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
mammography
ultrasound
mammography and ultrasound
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Breast Cancer focused on measuring breast cancer, screening, mammography, ultrasound

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Peking Union Medical College Hospital
  • Beijing ChaoYang Hospital affiliated to the Capital Medical University
  • Beijing Hospital affiliated to Ministry of Health
  • Chinese 307 Hospital affiliated to the People's Liberation Army
  • First Hospital affiliated to Peking University
  • The Cancer Institute & Hospital, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
  • The General Hospital affiliated to Beijing Military Area Command
  • Southwest Hospital affiliated to the Third Military Medical University
  • Population and Family Planning Service Center of Zhuhai
  • Maternity & Child Care Center of Qinhangdao
  • YingBin Surgery Hospital of Yancheng
  • The Cancer Hospital affiliated to Fudan University
  • ShanXi Traditional Medicine Hospital
  • The Cancer Hospital affiliated to Tianjin Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

group 1

group 2

group 3

Arm Description

screening with mammography alone

screening with ultrasonography alone

screening with both mammography and ultrasound

Outcomes

Primary Outcome Measures

screening yield
Sensitivities, specificities, positive predictive values, and negative predictive values

Secondary Outcome Measures

Cost-effectiveness
cost of each screening modility to detect one cancer

Full Information

First Posted
June 14, 2013
Last Updated
September 7, 2013
Sponsor
Peking Union Medical College Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01880853
Brief Title
Ultrasound and Mammography for Screening Breast Cancer in Chinese Women
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer, screening, mammography, ultrasound

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
47709 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group 1
Arm Type
Experimental
Arm Description
screening with mammography alone
Arm Title
group 2
Arm Type
Experimental
Arm Description
screening with ultrasonography alone
Arm Title
group 3
Arm Type
Experimental
Arm Description
screening with both mammography and ultrasound
Intervention Type
Other
Intervention Name(s)
mammography
Intervention Description
participants were screened by mammography alone every year
Intervention Type
Other
Intervention Name(s)
ultrasound
Intervention Description
participants were screened by ultrasound alone every year
Intervention Type
Other
Intervention Name(s)
mammography and ultrasound
Intervention Description
Participants were screened by both mammography and ultrasound every year
Primary Outcome Measure Information:
Title
screening yield
Description
Sensitivities, specificities, positive predictive values, and negative predictive values
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Cost-effectiveness
Description
cost of each screening modility to detect one cancer
Time Frame
3 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sun Qiang, MD
Organizational Affiliation
PUMCH
Official's Role
Study Chair
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Beijing ChaoYang Hospital affiliated to the Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Beijing Hospital affiliated to Ministry of Health
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Chinese 307 Hospital affiliated to the People's Liberation Army
City
Beijing
State/Province
Beijing
Country
China
Facility Name
First Hospital affiliated to Peking University
City
Beijing
State/Province
Beijing
Country
China
Facility Name
The Cancer Institute & Hospital, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
Country
China
Facility Name
The General Hospital affiliated to Beijing Military Area Command
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Southwest Hospital affiliated to the Third Military Medical University
City
Chongqing
State/Province
Chongqing
Country
China
Facility Name
Population and Family Planning Service Center of Zhuhai
City
Zhuhai
State/Province
Guangdong
Country
China
Facility Name
Maternity & Child Care Center of Qinhangdao
City
Qinhuangdao
State/Province
Hebei
Country
China
Facility Name
YingBin Surgery Hospital of Yancheng
City
Yancheng
State/Province
Jiangsu
Country
China
Facility Name
The Cancer Hospital affiliated to Fudan University
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
ShanXi Traditional Medicine Hospital
City
Taiyuan
State/Province
Shanxi
Country
China
Facility Name
The Cancer Hospital affiliated to Tianjin Medical University
City
Tianjin
State/Province
Tianjin
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
25668012
Citation
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.
Results Reference
derived

Learn more about this trial

Ultrasound and Mammography for Screening Breast Cancer in Chinese Women

We'll reach out to this number within 24 hrs