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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028398
Receipt No. 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 2017/11/27

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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
Middle name
Last name Motohiro Kojima
Organization National Cancer Center
Division name Exploratory Oncology research & Clinical Trial Center
Zip code
Address 6-5-1 Kashiwanoha, Kashiwa, Chiba
TEL 04-7133-1111
Email mokojima@east.ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Chisako Yamauchi
Organization National Cancer Center Hospital East
Division name Breast Surgery Division
Zip code
Address 6-5-1 Kashiwanoha, Kashiwa, Chiba
TEL 04-7133-1111
Homepage URL
Email cyamauch@east.ncc.go.jp

Sponsor
Institute National Cancer Center
Institute
Department

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
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
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 Enrolling by invitation
Date of protocol fixation
2017 Year 07 Month 14 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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
2017 Year 11 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032514

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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