UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011475 |
|---|---|
| Receipt number | 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 13:23:49 |
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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
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
kubota-cbu@umin.ac.jp
Sponsor or person
Institute
Department of Plastic Surgery, Chiba University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013430
