UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Post-operative changes in various parameters to detect the onset of post-mastectomy upper extremity lymphedema.
Title of the study (Brief title)	Non-invasive methods to detect post-mastectomy lymphedema.
Region	Japan

Condition
Condition	Lymphedema
Classification by specialty	Vascular surgery Breast surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To elucidate the changes in subjective symptom regarding edema, arm circumference, bioimpedance, and subcutaneous echogenicity for 2 years from mastectomy.
Basic objectives2	Others
Basic objectives -Others	Until present, the changes in subjective symptom regarding edema, arm circumference, bioimpedance, and subcutaneous echogenicity has not been elucidated. Observation of these parameters may help in detecting lymphedema, as well as differentiating the other types of post-mastectomy arm edema.
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The changes in subjective symptom regarding edema, arm circumference, bioimpedance, and subcutaneous echogenicity for 2 years from mastectomy.
Key secondary outcomes	The sensitivity of subjective symptom regarding edema, arm circumference, bioimpedance, and subcutaneous echogenicity to detect arm lymphedema.

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	99 years-old >
Gender	Male and Female
Key inclusion criteria	All the patients who will have mastectomy for breast cancer at Yamaguchi University Hospital between January, 2015 and February 2016.
Key exclusion criteria	The patient who cannot participate in this study for physical and/or mental problem.
Target sample size	120

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 755-8505
TEL	0836-22-2261
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 755-8505
TEL	0836-22-2261
Homepage URL
Email	ksuehiro@yamaguchi-u.ac.jp

Sponsor
Institute	Yamaguchi University Graduate School of Medicine, Department of Surgery and Clinical Science
Institute
Department

Funding Source
Organization	Yamaguchi University Graduate School of Medicine, Department of Surgery and Clinical Science
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	2014 Year 12 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 11 Month 28 Day
Anticipated trial start date	2015 Year 01 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	No data

Management information
Registered date	2014 Year 11 Month 28 Day
Last modified on	2018 Year 12 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018364