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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000000757
Receipt No. 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

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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
Email 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/
Email narikawayoko@gmail.com

Sponsor
Institute Division of Surgical Oncology, Graduate School of Medicine, TOHOKU UNIVERSITY
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000910

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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