UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004772 |
|---|---|
| Receipt number | R000005609 |
| Scientific Title | Study for new treatment methods and classifications of severity based on lymph function in patients with primary lymphedema |
| Date of disclosure of the study information | 2010/12/22 |
| Last modified on | 2020/01/21 13:01:06 |
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Basic information
Public title
Study for new treatment methods and classifications of severity based on lymph function in patients with primary lymphedema
Acronym
Study for new treatment methods and classifications in primary lympedema
Scientific Title
Study for new treatment methods and classifications of severity based on lymph function in patients with primary lymphedema
Scientific Title:Acronym
Study for new treatment methods and classifications in primary lympedema
Region
| Japan |
Condition
Condition
primary lymphedema
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
study for new treatment methods and classifications in primary lymphedema
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
physical examinations for lymphedema
functional evaluations for lymph
Key secondary outcomes
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
Treatment
Type of intervention
| Gene | Device,equipment | Maneuver |
Interventions/Control_1
Period of 5 years
lymphoscintigraphy, fluorescence lymphography once or twice a year and, skin biopsy 1 or 2 times a year and physical examination 3-4 times a year
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
| 0 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
primary lymphedema
Key exclusion criteria
other lymphedema
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Maegawa Jiro |
Organization
Yokohama City University Hospital
Division name
Plastic and Reconstructive Surgery
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004
TEL
045-787-2800
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Maegawa Jiro |
Organization
Yokohama City University Hospital
Division name
Plastic and Reconstructive Surgery
Zip code
Address
TEL
Homepage URL
maegawaj@med.yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Hospital
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University Hospital
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
Address
Tel
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
横浜市立大学
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 12 | Month | 22 | 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
| 2010 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2010 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 12 | Month | 22 | Day |
Last modified on
| 2020 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005609
