UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027470 |
|---|---|
| Receipt number | R000031456 |
| Scientific Title | Prospectively Assigned Database for Lymphedema |
| Date of disclosure of the study information | 2017/07/03 |
| Last modified on | 2023/11/27 14:14:13 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
tayamamoto@hosp.ncgm.go.jp
Public contact
Name of contact person
| 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
165-0035
Address
1-21-1 Toyama Shinjuku-ku, Tokyo, 162-8655, JAPAN
TEL
+81-3-3202-7181
Homepage URL
tyamamoto-tky@umin.ac.jp
Sponsor or person
Institute
The National Center for Global Health and Medicine
Institute
Department
Personal name
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
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
| 2023 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.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 |
