UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032413 |
|---|---|
| Receipt number | R000036965 |
| Scientific Title | Development of new pathological evaluation methods for human lymphedema |
| Date of disclosure of the study information | 2018/04/30 |
| Last modified on | 2024/05/13 12:09:37 |
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Basic information
Public title
Development of new pathological evaluation methods for human lymphedema
Acronym
Development of evaluation methods for human lymphedema
Scientific Title
Development of new pathological evaluation methods for human lymphedema
Scientific Title:Acronym
Development of evaluation methods for human lymphedema
Region
| Japan |
Condition
Condition
lymphedema
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the usefulness of CT, MRI, skin hardness meter, skin elasticity meter, and limb volume measuring device for the evaluation of human lymphedema
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
skin elasticity
Key secondary outcomes
skin hardness
limb volume
Subcutaneous fat mass (CT)
Skin hardness (MRI)
Limb circumference
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Once at the consultation
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with lymphedema visited our hospital
Over 20 years old
Patients who agreed to participate in this research
Key exclusion criteria
Patients judged inappropriate by the attending physician
Patients who do not agreed to participate in this research
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Sano |
Organization
Hamamatsu University School of Medicine
Division name
Second Department of Surgery
Zip code
4313192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan
TEL
053-435-2279
m.sano@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Sano |
Organization
Hamamatsu University School of Medicine
Division name
Second Department of Surgery
Zip code
4313192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan
TEL
053-435-2279
Homepage URL
m.sano@hama-med.ac.jp
Sponsor or person
Institute
Japan Science and Technology Agency
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan
Tel
053-435-2279
m.sano@hama-med.ac.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
| 2018 | Year | 04 | Month | 30 | 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
| 2016 | Year | 04 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 15 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 30 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 27 | Day |
Last modified on
| 2024 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036965
