UMIN-CTR Clinical Trial

Basic information
Public title	Development of an early detection program for the patients with lymphedema related breast cancer
Acronym	Development of an early detection program for the patients with lymphedema related breast cancer
Scientific Title	Development of an early detection program for the patients with lymphedema related breast cancer
Scientific Title:Acronym	Development of an early detection program for the patients with lymphedema related breast cancer
Region	Japan

Condition
Condition	secondary lymphedema
Classification by specialty	Breast surgery Plastic surgery Rehabilitation medicine Nursing
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the change of body shape in early detection of lymphedema
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	circumference length of the trunk
Key secondary outcomes	A value of segmental body composition measurement Limb circumference length Limb volume Viscoelasticity on skin surface MR image Ultrasonic echo image of the subcutaneous tissue Lymphedema related symptoms

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	90 years-old >
Gender	Female
Key inclusion criteria	1.Patients plan to undergo surgery or after surgery for breast cancer 2.Got the medical doctore's approval to take this study(e.g. MRI) 3.The purpose and analysis of this study have all consented
Key exclusion criteria	1.Cancer recurrence 2.Patients who have trauma with deformation, degenerative diseases or inflammatory diseases in the trunk or upper extremities, now or in the past
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Chika Middle name Last name Oshima
Organization	Nagoya University, Graduate School of Medicine
Division name	Department of Nursing
Zip code	461-8673
Address	1-1-20 Daiko-minami Higashi-ku Nagoya city, Aichi 461-8673 Japan
TEL	052-719-3101
Email	chika@met.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Fumiya Middle name Last name Hisano
Organization	Graduate school of medicine, Nagoya university
Division name	Department of Nursing
Zip code	461-8673
Address	1-1-20 Daiko-minami Higashi-ku Nagoya city, Aichi 461-8673 Japan
TEL	052-719-3101
Homepage URL
Email	hisano@met.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University, Graduate School of Medicine
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
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	The Ethics Committees of Nagoya University
Address	65 Tsurumai, Syowa-ku, Nagoya-city
Tel	052-744-2479
Email	052-744-2479

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	2018 Year 10 Month 10 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	Enrolling by invitation
Date of protocol fixation	2018 Year 10 Month 10 Day
Date of IRB	2018 Year 12 Month 05 Day
Anticipated trial start date	2018 Year 11 Month 01 Day
Last follow-up date	2027 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Observational study All the patients who apply criteria for selection Circumference length & volume A value of segmental body composition measurement Viscoelasticity on skin surface MR image Ultrasonic echo image of the subcutaneous tissue Lymphedema related symptoms

Management information
Registered date	2018 Year 10 Month 05 Day
Last modified on	2022 Year 09 Month 09 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039213