UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000757 |
|---|---|
| Receipt number | R000000910 |
| Scientific Title | Randomized controlled trial on effectiveness of ultrasonography in breast cancer screening(Japan Strategic Anti-Cancer Randomized Trial) |
| Date of disclosure of the study information | 2007/07/01 |
| Last modified on | 2016/01/29 11:25:29 |
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Basic information
Public title
Randomized controlled trial on effectiveness of ultrasonography in breast cancer screening(Japan Strategic Anti-Cancer Randomized Trial)
Acronym
RCT on ultrasonography in breast cancer screening(J-START)
Scientific Title
Randomized controlled trial on effectiveness of ultrasonography in breast cancer screening(Japan Strategic Anti-Cancer Randomized Trial)
Scientific Title:Acronym
RCT on ultrasonography in breast cancer screening(J-START)
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Breast surgery | Laboratory medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verify quality and effectiveness of ultrasonography in breast cancer screening
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Sensitivity, specificity and detection rate of breast cancer
Key secondary outcomes
Accumulated incidence rate of advanced breast cancer
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Ultrasonography added to mammography
Interventions/Control_2
Mammography
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| 49 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Women aged 40 to 49 years when registered.
2. Women signed the informed consent to participate in the study.
Key exclusion criteria
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.
Target sample size
100000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | NORIAKI OHUCHI |
Organization
TOHOKU UNIVERSITY
Division name
Division of Surgical Oncology, Graduate School of Medicine
Zip code
Address
Seiryo-machi 1-1, Aoba-ku, Sendai, Miyagi
TEL
022-717-7214
noriaki-ohuchi@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | YOKO NARIKAWA |
Organization
TOHOKU UNIVERSITY
Division name
J-START research unit
Zip code
Address
5S-05, Innovation of New Biomedical Enginnering Center, Seiryo-machi 1-1, Aoba-ku, Sendai, Miyagi
TEL
022-272-3011
Homepage URL
http://www.j-start.org/
narikawayoko@gmail.com
Sponsor or person
Institute
Division of Surgical Oncology, Graduate School of Medicine, TOHOKU UNIVERSITY
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Japan Cancer Society. Japan Clinical Research Unit.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
宮城県医師会健康センター（宮城県）、つくば総合健診センター（茨城県）、茨城県メディカルセンター（茨城県）、茨城県総合健診協会（茨城県）、川越市保健所（埼玉県）、神奈川県厚生連保健福祉センター（神奈川県）、岡山県健康づくり財団（岡山県）、宮城県対がん協会（宮城県）、山形県結核成人病予防協会（山形県）、北海道対がん協会（北海道）、札幌社会保険病院（札幌）、岩手県予防医学協会（岩手県）、石巻市医師会検診部（宮城県）、栃木県保健衛生事業団（栃木県）、埼玉県健康づくり財団（埼玉県）、福井県済生会病院健診センター（福井県）、倉敷中央病院総合保健管理センター（岡山県）、倉敷成人病健診センター（岡山県）、水島協同病院（岡山県）、広島県健康福祉センター（広島県）、熊本県総合保健センター（熊本県）、久留米医師会（福岡県）、福岡市医師会（福岡県）、岩手県対ガン協会（岩手県）、群馬県健康づくり財団（群馬県）、鶴岡地区医師会荘内地区健康管理センター（山形県）、福島県郡山市（福島県）、宇都宮東病院健診センター（栃木県）、東京都予防医学協会（東京都）、足立区医師会（東京都）、富山県健康増進センター（富山県）、浜松市医師会（静岡県）、磐田市立総合病院健診センター（静岡県）、八尾市立病院（大阪府）、オリエンタル労働衛生協会（愛知県）、中日病院（愛知県）、岡山大福クリニック（岡山県）、岡山済生会病院（岡山県）、福山市医師会総合健診センター（岡山県）、中部地区医師会立成人病健診センター（沖縄県）、沖縄県総合保健協会（沖縄県）
Other administrative information
Date of disclosure of the study information
| 2007 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
http://www.j-start.org/index.html
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2007 | Year | 06 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
| 2016 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 06 | Month | 29 | Day |
Last modified on
| 2016 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000910
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
