UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017736 |
|---|---|
| Receipt number | R000020546 |
| Scientific Title | Study on the correlation among the changes in extremity volume, extracellular fluid volume, and subcutaneous inflammatory change in the upper extremity lymphedema. |
| Date of disclosure of the study information | 2015/06/01 |
| Last modified on | 2017/05/30 08:21:33 |
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Basic information
Public title
Study on the correlation among the changes in extremity volume, extracellular fluid volume, and subcutaneous inflammatory change in the upper extremity lymphedema.
Acronym
Changes in arm volume, fluid volume, and inflammation in lymphedema
Scientific Title
Study on the correlation among the changes in extremity volume, extracellular fluid volume, and subcutaneous inflammatory change in the upper extremity lymphedema.
Scientific Title:Acronym
Changes in arm volume, fluid volume, and inflammation in lymphedema
Region
| Japan |
Condition
Condition
lymphedema
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the impact of changes in extracellular fluid and subcutaneous tissue inflammation on the extremity volume of the arm with lymphedema.
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in arm volume, bioimpedance, and subcutaneous echogenicity during 6-12 months period.
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients with arm lymphedema who are attending lymphedema clinic of Yamaguchi University Hospital
2. Patients without cancer recurrence
3. Patients who are not on chemotherapy
3.Patients who consented
Key exclusion criteria
The patients who suffer physical or mental trouble during study and the investigator decided that prper data collection is difficult from them.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kimikazu Hamano |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Surgery and Clinical Science
Zip code
Address
1-1-1 Minamikogushi, Ube, Yamaguchi, Japan
TEL
+81-836-22-2260
kimikazu@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kotaro Suehiro |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Surgery and Clinical Science
Zip code
Address
1-1-1 Minamikogushi, Ube, Yamaguchi, Japan
TEL
+81-836-22-2260
Homepage URL
ksuehiro-circ@umin.ac.jp
Sponsor or person
Institute
Yamaguchi University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Yamaguchi University Graduate School of Medicine
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 01 | 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
| 2015 | Year | 05 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing
Management information
Registered date
| 2015 | Year | 05 | Month | 29 | Day |
Last modified on
| 2017 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020546
