UMIN-CTR Clinical Trial

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
Email	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
Email	sugitaka@tottori-u.ac.jp

Sponsor
Institute	Tottori University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000051704