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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034395
Receipt No. R000039213
Scientific Title Development of an early detection program for the patients with lymphedema related breast cancer
Date of disclosure of the study information 2018/10/10
Last modified on 2018/10/05

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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 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
Middle name
Last name Chika Oshima
Organization Nagoya University,
Graduate School of Medicine
Division name Department of Nursing
Zip code
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
Middle name
Last name Fumiya Hisano
Organization Graduate school of medicine, Nagoya university
Division name Doctoral course
Zip code
Address 1-1-20 Daiko-minami Higashi-ku Nagoya city, Aichi 461-8673 Japan
TEL 052-719-3101
Homepage URL
Email kurono.fumiya@f.mbox.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
Address
Tel
Email

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 Preinitiation
Date of protocol fixation
2018 Year 10 Month 10 Day
Date of IRB
Anticipated trial start date
2018 Year 11 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 Cohort 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
2018 Year 10 Month 05 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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