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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011475
Receipt No. R000013430
Scientific Title Research for establishing the best algorithm for breast reconstruction in Japan
Date of disclosure of the study information 2013/08/14
Last modified on 2013/08/16

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Basic information
Public title Research for establishing the best algorithm for breast reconstruction in Japan
Acronym Breast reconstruction algorithm in Japan
Scientific Title Research for establishing the best algorithm for breast reconstruction in Japan
Scientific Title:Acronym Breast reconstruction algorithm in Japan
Region
Japan

Condition
Condition Breast cancer
Classification by specialty
Breast surgery Plastic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To establish the best algorithm for breast reconstruction in Japan
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Patient's satisfaction after breast reconstruction
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Patients who provided written consent form on their voluntary basis.
Key exclusion criteria Patients who were judged inappropriate as subjects
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshitaka Kubota
Organization Chiba University
Division name Department of Plastic Surgery
Zip code
Address 1-8-1, Inohana, Chuo-ku, Chiba-city, Japan
TEL 81-43-222-7171
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoshtiaka Kubota
Organization Chiba University
Division name Department of Plastic Surgery
Zip code
Address 1-8-1, Inohana, Chuo-ku, Chiba-city, Japan
TEL 043-222-7171
Homepage URL
Email kubota-cbu@umin.ac.jp

Sponsor
Institute Department of Plastic Surgery, Chiba University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2013 Year 08 Month 14 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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 Open public recruiting
Date of protocol fixation
2012 Year 09 Month 26 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Uncontrolled, non-randomized, open-label

Management information
Registered date
2013 Year 08 Month 13 Day
Last modified on
2013 Year 08 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013430

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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