UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058749 |
|---|---|
| Receipt number | R000067175 |
| Scientific Title | Prospective Study on Treatment Outcomes and Quality of Life Improvement in Lymphedema and Other Lymphatic Disorders |
| Date of disclosure of the study information | 2025/08/09 |
| Last modified on | 2025/08/09 12:47:42 |
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Basic information
Public title
Prospective Study on Treatment Outcomes and Quality of Life Improvement in Lymphedema and Other Lymphatic Disorders
Acronym
Prospective Study on Treatment Outcomes and Quality of Life Improvement in Lymphedema and Other Lymphatic Disorders
Scientific Title
Prospective Study on Treatment Outcomes and Quality of Life Improvement in Lymphedema and Other Lymphatic Disorders
Scientific Title:Acronym
Prospective Study on Treatment Outcomes and Quality of Life Improvement in Lymphedema and Other Lymphatic Disorders
Region
| Japan |
Condition
Condition
Lymphedema and Other Lymphatic Disorders
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prospectively evaluate clinical outcomes in patients with lymphedema and other lymphatic disorders, and to assess the usefulness and validity of our diagnostic and therapeutic approaches.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in clinical symptoms and anthropometric measurements before and after treatment (e.g., limb circumference, severity of edema, skin changes)
Key secondary outcomes
Changes in quality of life (QOL) scores, assessed by standardized questionnaires such as the Lymphedema Quality of Life Inventory or SF-36
Changes in functional status (e.g., activities of daily living [ADL] scores, patient-reported outcomes)
Incidence of complications such as cellulitis
Changes in imaging findings (e.g., lymphangiography, lymphoscintigraphy)
Recurrence rates and need for additional treatment during follow-up
Domain-specific QOL analysis (physical, mental, and social functioning)
Exploratory analyses using other clinically relevant parameters obtainable from medical records and patient questionnaires
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
Patients who visited the outpatient clinic of Mukumi Clinic between April 1, 2025, and March 31, 2030, and were diagnosed with lymphedema or other lymphatic disorders, who meet the following conditions:
Provided signed consent regarding academic presentations and publications at the time of the first visit to Mukumi Clinic or equivalent.
Underwent examination, treatment, or surgery at Mukumi Clinic during the study period.
Key exclusion criteria
Patients deemed unsuitable for inclusion in the study by the principal investigator.
Patients who declined to participate in the study.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Mihara |
Organization
Mukumi Clinic
Division name
Clinical Department
Zip code
151-0053
Address
3F, toDOe Yoyogi Building, 1-35-3 Yoyogi, Shibuya-ku, Tokyo, 151-0053, Japan
TEL
050-3146-4579
mihara.plasticsurgery@gmail.com
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Mihara |
Organization
Mukumi Clinin
Division name
Clinical Department
Zip code
151-0053
Address
3F, toDOe Yoyogi Building, 1-35-3 Yoyogi, Shibuya-ku, Tokyo, 151-0053, Japan
TEL
050-3146-4579
Homepage URL
mihara.plasticsurgery@gmail.com
Sponsor or person
Institute
Mukumi Clinic
Institute
Department
Personal name
Funding Source
Organization
Mukumi Clinic
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee, Aichi Medical University
Address
1-1 Yazako Karimata, Nagakute, Aichi 480-1195, Japan
Tel
0561-62-3311
amu_crb@aichi-med-u.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
| 2025 | Year | 08 | Month | 09 | 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
| 2025 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 15 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single-center, prospective observational study utilizing clinical data from Mukumi Clinic. The study will include patients who visit our clinic between April 1, 2025, and March 31, 2030, and are diagnosed with lymphedema or other lymphatic disorders. Comprehensive informed consent for the use of clinical data for research purposes will be obtained at the initial visit. Outcome measures include limb circumference, incidence of cellulitis, pain (VAS), tissue stiffness, laboratory data, imaging findings, surgical information, patient satisfaction, and quality of life (QOL) scores, which will be compared before and after treatment. Diagnostic modalities include lymphoscintigraphy, indocyanine green (ICG) lymphography, and ultrasonography. For LVA surgery, postoperative complication rates and outcomes of day surgery will also be evaluated. All clinical data and medical images will be anonymized, and statistical analyses will be performed. In addition, natural language processing, machine learning algorithms, and deep learning techniques will be applied as supplemental AI tools to integrate multidimensional information, aiming to comprehensively evaluate the usefulness and validity of treatment from multiple perspectives.
Management information
Registered date
| 2025 | Year | 08 | Month | 09 | Day |
Last modified on
| 2025 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067175
