UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057067 |
|---|---|
| Receipt number | R000065231 |
| Scientific Title | Tissue analysis and verification of treatment methods for establishing treatment methods for patients with lymphedema |
| Date of disclosure of the study information | 2025/02/18 |
| Last modified on | 2025/02/18 23:12:45 |
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Basic information
Public title
Tissue analysis and verification of treatment methods for establishing treatment methods for patients with lymphedema
Acronym
Tissue analysis and validation of treatment methods for lymphedema patients
Scientific Title
Tissue analysis and verification of treatment methods for establishing treatment methods for patients with lymphedema
Scientific Title:Acronym
Tissue analysis and validation of treatment methods for lymphedema patients
Region
| Japan |
Condition
Condition
Lymphedema
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to collect and analyze tissue data from lymphedema patients.
Basic objectives2
Others
Basic objectives -Others
We will accumulate and analyze tissue data from lymphedema patients to elucidate the pathophysiology of lymphedema and to explore possible treatment methods.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
None
Key secondary outcomes
None
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
1. Patients diagnosed with lymphedema and undergoing surgical treatment for lymphedema. (Required for lymphedema patient data for this study) 2. patients who have undergone skin valvuloplasty for any defect and have excess cutaneous fatty tissue
2. patients who have undergone skin valvuloplasty for any defect and have excess cutaneous adipose tissue, or who have undergone immediate lymphatic leakage treatment after tumor resection, or who will undergo lymph node transplantation (required as healthy data for this study).
Key exclusion criteria
(1) Cases in which the patient or a surrogate has indicated his/her refusal at the time of consenting to participate in this study (as is the patient's right).
(2) Other cases in which the responsible person has judged that the subject is inappropriate as a research subject (in the case of insufficient data).
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | Kishi |
Organization
Keio University School of Medicine
Division name
Department of Plastic and Reconstructive surgery
Zip code
1608582
Address
Shinanomachi 35 Shinjuku
TEL
0353633814
kkishi@keio.jp
Public contact
Name of contact person
| 1st name | Yushi |
| Middle name | |
| Last name | Suzuki |
Organization
Keio University School of Medicine
Division name
Department of Plastic and Reconstructive surgery
Zip code
1608582
Address
Shinanomachi 35 Shinjuku
TEL
0353633814
Homepage URL
fi080150@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
None
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
Keio University School of Medicine
Address
Shinanomachi 35 Shinjuku
Tel
0353633814
fi080150@keio.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
| 2025 | Year | 02 | Month | 18 | 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
| 2023 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 28 | Day |
Last follow-up date
| 2033 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. In the case of patients with lymphoedema, a sample will be taken for experimental purposes during surgical treatment of the lymphoedema.
2. In the case of healthy lymph vessels, a sample will be taken from the excess skin fat tissue and the lymph vessels contained within.
Therefore, there will be no additional invasion involved in participating in this research.
Management information
Registered date
| 2025 | Year | 02 | Month | 18 | Day |
Last modified on
| 2025 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065231
