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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name