UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015780 |
|---|---|
| Receipt number | R000018364 |
| Scientific Title | Post-operative changes in various parameters to detect the onset of post-mastectomy upper extremity lymphedema. |
| Date of disclosure of the study information | 2014/12/01 |
| Last modified on | 2018/12/02 09:20:20 |
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Basic information
Public title
Post-operative changes in various parameters to detect the onset of post-mastectomy upper extremity lymphedema.
Acronym
Non-invasive methods to detect post-mastectomy lymphedema.
Scientific Title
Post-operative changes in various parameters to detect the onset of post-mastectomy upper extremity lymphedema.
Scientific Title:Acronym
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
| 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 755-8505
TEL
0836-22-2261
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 755-8505
TEL
0836-22-2261
Homepage URL
ksuehiro@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University Graduate School of Medicine, Department of Surgery and Clinical Science
Institute
Department
Personal name
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)
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
| 2014 | Year | 12 | 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
| 2014 | Year | 11 | Month | 28 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018364
