UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on the correlation among the changes in extremity volume, extracellular fluid volume, and subcutaneous inflammatory change in the upper extremity lymphedema.
Title of the study (Brief title)	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	Kimikazu Hamano
Organization	Yamaguchi University Graduate School of Medicine
Division name	Department of Surgery and Clinical Science
Address	1-1-1 Minamikogushi, Ube, Yamaguchi, Japan
TEL	+81-836-22-2260
Email	kimikazu@yamaguchi-u.ac.jp

Public contact
Name of contact person	Kotaro Suehiro
Organization	Yamaguchi University Graduate School of Medicine
Division name	Department of Surgery and Clinical Science
Address	1-1-1 Minamikogushi, Ube, Yamaguchi, Japan
TEL	+81-836-22-2260
Homepage URL
Email	ksuehiro-circ@umin.ac.jp

Sponsor
Institute	Yamaguchi University Graduate School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 05 Month 26 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020546