Randomized controlled trial on effectiveness of ultrasonography in breast cancer screening(Japan Strategic Anti-Cancer Randomized Trial)
- Conditions
- Breast Cancer
- Registration Number
- JPRN-UMIN000000757
- Lead Sponsor
- Division of Surgical Oncology, Graduate School of Medicine, TOHOKU UNIVERSITY
- Brief Summary
A. Study Results 1. Standardization and propagation of breast cancer screening with ultrasonography: We formulated "Guidelines for Ultrasonography in Breast Cancer Screening" (Japanese and English versions) in 2007. Further, we developed a breast ultrasonography workshop in line with the Guidelines in order to disseminate the use of breast ultrasonography and provide education, training, and quality control for the institutions. 2. Implementation of a randomized controlled trial (RCT) to examine the effectiveness of ultrasonography: a. A total of 76,196 women in their 40's given informed-consent and participated in the RCT after the study were initiated. b. This is a nationwide study, with participation of 41 institutions from 23 prefectures. Study participation of the groups began in 2007, respectively, demonstrating the feasibility of large-scale clinical trials in Japan.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- Female
- Target Recruitment
- 100000
Not provided
1. Women with history of breast cancer. 2. Women with history of malignant disease other than breast cancer within 5 years. 3. Women in severe condition, who are not expected to live for 5 years.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sensitivity, specificity and detection rate of breast cancer
- Secondary Outcome Measures
Name Time Method Accumulated incidence rate of advanced breast cancer