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Ultrasound and Mammography for Screening Breast Cancer in Chinese Women

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ClinicalTrials.gov Identifier: NCT01880853
Recruitment Status : Completed
First Posted : June 19, 2013
Last Update Posted : September 10, 2013
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Other: mammography Other: ultrasound Other: mammography and ultrasound Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47709 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Study Start Date : November 2008
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: group 1
screening with mammography alone
Other: mammography
participants were screened by mammography alone every year

Experimental: group 2
screening with ultrasonography alone
Other: ultrasound
participants were screened by ultrasound alone every year

Experimental: group 3
screening with both mammography and ultrasound
Other: mammography and ultrasound
Participants were screened by both mammography and ultrasound every year




Primary Outcome Measures :
  1. screening yield [ Time Frame: 3 years ]
    Sensitivities, specificities, positive predictive values, and negative predictive values


Secondary Outcome Measures :
  1. Cost-effectiveness [ Time Frame: 3 years ]
    cost of each screening modility to detect one cancer



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01880853


Locations
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China, Beijing
Peking Union Medical College Hospital
Beijing, Beijing, China, 100730
Beijing ChaoYang Hospital affiliated to the Capital Medical University
Beijing, Beijing, China
Beijing Hospital affiliated to Ministry of Health
Beijing, Beijing, China
Chinese 307 Hospital affiliated to the People's Liberation Army
Beijing, Beijing, China
First Hospital affiliated to Peking University
Beijing, Beijing, China
The Cancer Institute & Hospital, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing, China
The General Hospital affiliated to Beijing Military Area Command
Beijing, Beijing, China
China, Chongqing
Southwest Hospital affiliated to the Third Military Medical University
Chongqing, Chongqing, China
China, Guangdong
Population and Family Planning Service Center of Zhuhai
Zhuhai, Guangdong, China
China, Hebei
Maternity & Child Care Center of Qinhangdao
Qinhuangdao, Hebei, China
China, Jiangsu
YingBin Surgery Hospital of Yancheng
Yancheng, Jiangsu, China
China, Shanghai
The Cancer Hospital affiliated to Fudan University
Shanghai, Shanghai, China
China, Shanxi
ShanXi Traditional Medicine Hospital
Taiyuan, Shanxi, China
China, Tianjin
The Cancer Hospital affiliated to Tianjin Medical University
Tianjin, Tianjin, China
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
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Study Chair: Sun Qiang, MD PUMCH

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT01880853     History of Changes
Other Study ID Numbers: PUMCH-breast-screening
First Posted: June 19, 2013    Key Record Dates
Last Update Posted: September 10, 2013
Last Verified: September 2013
Keywords provided by Peking Union Medical College Hospital:
breast cancer
screening
mammography
ultrasound
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases