UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045266 |
|---|---|
| Receipt number | R000051704 |
| Scientific Title | A study of the relationship between the shape feature measurements of the lower limb images and sarcopenia. |
| Date of disclosure of the study information | 2021/08/25 |
| Last modified on | 2022/10/18 10:07:44 |
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Basic information
Public title
A study of imaging detection of sarcopenia.
Acronym
A study of imaging detection of sarcopenia.
Scientific Title
A study of the relationship between the shape feature measurements of the lower limb images and sarcopenia.
Scientific Title:Acronym
A study of the relationship between the shape measurements of lower limb images and sarcopenia.
Region
| Japan |
Condition
Condition
Sarcopenia
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether quantitative values of lower limb shape measured from images are useful in screening for sarcopenia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Determine the cutoff value between the non-sarcopenia and sarcopenia groups by measuring the shape of the lower limbs based on images and actual measurements.
Key secondary outcomes
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Must be an adult (greater than or equal to20 years old).
Key exclusion criteria
1)Highly obese patients (more than BMI35kg/m^2).
2)Patients with edema of the lower limbs (regardless of whether it is indented or non-indented).
3)Those who cannot be measured by body composition analyzer.
4)Patients who have been hospitalized or admitted for more than 3 months.
5)Those who are judged by the principal investigator to be inappropriate as patients.
Target sample size
750
Research contact person
Name of lead principal investigator
| 1st name | Takaaki |
| Middle name | |
| Last name | Sugihara |
Organization
Faculty of Medicine, Tottori University
Division name
Department of Gastroenterology and Nephrology
Zip code
6838504
Address
36-1 Nishi-cho, Yonago, Tottori, Japan
TEL
0859386527
sugitaka@tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | Takaaki |
| Middle name | |
| Last name | Sugihara |
Organization
Faculty of medicine, Tottori University
Division name
Department of Gastroenterology and Nephrology
Zip code
6838504
Address
36-1 Nishi-cho, Yonago, Tottori, Japan
TEL
0859386527
Homepage URL
sugitaka@tottori-u.ac.jp
Sponsor or person
Institute
Tottori University
Institute
Department
Personal name
Funding Source
Organization
Tottori University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Advanced Medicine, Innovation and Clinical Research Center, Tottori University Hospital
Address
36-1, Nishi-cho, Yonago city, Tottori prefecture, Japan
Tel
0859387108
me-rinshoukenkyu@ml.adm.tottori-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
| 2021 | Year | 08 | Month | 25 | 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
| 2021 | Year | 04 | Month | 16 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 16 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2021 | Year | 08 | Month | 25 | Day |
Last modified on
| 2022 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051704
