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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027470
Receipt No. R000031456
Scientific Title Prospectively Assigned Database for Lymphedema
Date of disclosure of the study information 2017/07/03
Last modified on 2019/06/03

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Basic information
Public title Prospectively Assigned Database for Lymphedema
Acronym Lymphedema Database (LED)
Scientific Title Prospectively Assigned Database for Lymphedema
Scientific Title:Acronym Lymphedema Database (LED)
Region
Japan

Condition
Condition Lymphedema
Classification by specialty
Plastic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is to obtain the patients' clinical information prospectively and develop a database of lymphedema management, which can be comprehensively analyzed afterward.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes This study analyzes changes in subjective symptoms or objective findings.
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 Male and Female
Key inclusion criteria This study includes all the patients who are diagnosed with lymphedema at Center Hospital of the National Center for Global Health and Medicine in Japan.
Key exclusion criteria Subjects who refuse to be registered
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Takumi
Middle name
Last name YAMAMOTO
Organization The National Center for Global Health and Medicine
Division name Plastic and Reconstructive Surgery
Zip code 162-8655
Address 1-21-1 Toyama Shinjuku-ku, Tokyo, 162-8655, JAPAN
TEL +81-3-3202-7181
Email tayamamoto@hosp.ncgm.go.jp

Public contact
Name of contact person
1st name Yuma
Middle name
Last name FUSE
Organization The National Center for Global Health and Medicine
Division name Plastic and Reconstructive Surgery
Zip code 162-8655
Address 1-21-1 Toyama Shinjuku-ku, Tokyo, 162-8655, JAPAN
TEL +81-3-3202-7181
Homepage URL
Email yfuse@hosp.ncgm.go.jp

Sponsor
Institute The National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization Not Applicable
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Center for Global Health and Medicine
Address 1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan
Tel +81-3-3202-7181
Email rinrijm@hosp.ncgm.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 国立国際医療研究センター(東京都)

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 03 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
2017 Year 04 Month 26 Day
Date of IRB
2017 Year 09 Month 08 Day
Anticipated trial start date
2017 Year 07 Month 03 Day
Last follow-up date
2029 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information In this study, subjective symptoms and objective findings are observed.

Management information
Registered date
2017 Year 05 Month 23 Day
Last modified on
2019 Year 06 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031456

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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