UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037595 |
|---|---|
| Receipt number | R000042865 |
| Scientific Title | Study on quantitative evaluation of superficial tissue in secondary lymphedema using ultrasonography |
| Date of disclosure of the study information | 2019/08/10 |
| Last modified on | 2022/02/15 11:56:09 |
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Basic information
Public title
Study on quantitative evaluation of superficial tissue in secondary lymphedema using ultrasonography
Acronym
Study on quantitative evaluation of superficial tissue in secondary lymphedema using ultrasonography
Scientific Title
Study on quantitative evaluation of superficial tissue in secondary lymphedema using ultrasonography
Scientific Title:Acronym
Study on quantitative evaluation of superficial tissue in secondary lymphedema using ultrasonography
Region
| Japan |
Condition
Condition
secondary lymphedema
Classification by specialty
| Breast surgery | Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To quantitatively capture the status of lymphatic fluid accumulation in the subcutaneous tissue of lymphedema using only ultrasound images.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ultrasound images of the subcutaneous tissue
Key secondary outcomes
A value of segmental body composition measurement
Limb circumference length
Limb volume
Viscoelasticity on skin surface
MR images
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)Unilateral secondary lymphedema
2)>=6 month from radiation treatment and /or chemotherapy
3)Got the medical doctore's approval to take this study(e.g. MRI)
4)The purpose and analysis of this study have all consented
Key exclusion criteria
1)Cancer recurrence
2)MRI examination is impossible (ex. Installation of pacemaker, claustrophobia)
Target sample size
20
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
chika@met.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Shiori |
| Middle name | |
| Last name | Niwa |
Organization
Nagoya University, Graduate School of Medicine
Division name
Doctoral course
Zip code
461-8673
Address
1-1-20 Daiko-minami Higashi-ku Nagoya city, Aichi 461-8673 Japan
TEL
052-719-3101
Homepage URL
niwa.shiori@j.mbox.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University, Graduate School of Medicine
Institute
Department
Personal name
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
no
Address
no
Tel
0527193101
niwa.shiori@j.mbox.nagoya-u.ac.jp
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
| 2019 | Year | 08 | 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
| 2019 | Year | 06 | Month | 18 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2024 | 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
Measurement:
Ultrasound images of the subcutaneous tissue
MR image
A value of segmental body composition measurement
Lymphedema related symp
Management information
Registered date
| 2019 | Year | 08 | Month | 05 | Day |
Last modified on
| 2022 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042865
