UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028398 |
|---|---|
| Receipt number | R000032514 |
| Scientific Title | Exploratory research in the utility of tactile sensor in the diagnosis of lymphedema after breast surgery. |
| Date of disclosure of the study information | 2017/08/01 |
| Last modified on | 2020/07/29 10:23:30 |
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Basic information
Public title
Exploratory research in the utility of tactile sensor in the diagnosis of lymphedema after breast surgery.
Acronym
Utility of tactile sensor in the diagnosis of lymphedema (UTSDL).
Scientific Title
Exploratory research in the utility of tactile sensor in the diagnosis of lymphedema after breast surgery.
Scientific Title:Acronym
Utility of tactile sensor in the diagnosis of lymphedema (UTSDL).
Region
| Japan |
Condition
Condition
Lymphedema after breasat surgery
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Aim of this study is to assess the utility of elastic sensor in the diagnosis of lymphedema by measuring elasticity of patients with lymphedema. Improvement of sensor as a medical devise is also performed.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Primary outcome is to confirm difference in the elasticity between patients with and without lymphedema.
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Breast cancer patients with and without lymphedema with impormed consensus.
Key exclusion criteria
Cases judged as inappropriate for this study.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Motohiro |
| Middle name | |
| Last name | Kojima |
Organization
National Cancer Center
Division name
Exploratory Oncology research & Clinical Trial Center
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba
TEL
04-7133-1111
mokojima@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Chisako |
| Middle name | |
| Last name | Yamauchi |
Organization
National Cancer Center Hospital East
Division name
Breast Surgery Division
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba
TEL
04-7133-1111
Homepage URL
cyamauch@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Murata Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center, Hospital East
Address
6-5-1 Kashiwa, Chiba, Japan
Tel
04-7133-1111
mokojima@east.ncc.go.jp
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
| 2017 | Year | 08 | Month | 01 | 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
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 14 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 14 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 13 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 06 | Month | 06 | Day |
Other
Other related information
Motohiro Kojima
National Cancer Center Epoc
Div. Pathology
6-5-1 Kashiwanoha, Chiba, 277-8577 Japan
TEL: 04-7133-1111
E-mail mokojima@east.ncc.go.jp
Management information
Registered date
| 2017 | Year | 07 | Month | 27 | Day |
Last modified on
| 2020 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032514
