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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032577
Receipt No. R000037149
Scientific Title A study to investigate the body composition using CT scan images in patients visiting a primary care hospital.
Date of disclosure of the study information 2018/05/13
Last modified on 2018/05/13

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Basic information
Public title A study to investigate the body composition using CT scan images in patients visiting a primary care hospital.
Acronym Body composition in patients visiting a primary care hospital.
Scientific Title A study to investigate the body composition using CT scan images in patients visiting a primary care hospital.
Scientific Title:Acronym Body composition in patients visiting a primary care hospital.
Region
Japan

Condition
Condition Patients visiting a primary care hospital
Classification by specialty
Medicine in general Surgery in general Hepato-biliary-pancreatic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the impact of background disease, lifestyle (eating habits, exercise habits, etc.), and blood test results on the body composition (muscle mass, fat mass, etc.) measured by the images of abdominal CT scan in patients visiting a primary care hospital.
Basic objectives2 Others
Basic objectives -Others To calculate the average muscle mass and fat mass by age and gender.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To investigate the impact of background disease, lifestyle (eating habits, exercise habits, etc.), and blood test results on the areas of total psoas muscle, visceral fat, subcutaneous fat, and mean CT number of the erector muscle of spine measured by the images of abdominal CT scan at the umbilical level.
Key secondary outcomes To calculate the average areas of total psoas muscle, visceral fat, subcutaneous fat, and mean CT number of the erector muscle of spine measured by the images of abdominal CT scan at the umbilical level by age and gender.

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
10 years-old <
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients visiting a primary care hospital
Key exclusion criteria Patients who reject to participate this study
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukihiro Yokoyama
Organization Nagoya University Graduate School of Medicine
Division name Division of Surgical Oncology, Department of Surgery
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL 052-744-2222
Email yyoko@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yukihiro Yokoyama
Organization Nagoya University Graduate School of Medicine
Division name Division of Surgical Oncology, Department of Surgery
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL 052-744-2222
Homepage URL
Email yyoko@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization Nagoya University Graduate School of Medicine
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 05 Month 13 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 Open public recruiting
Date of protocol fixation
2018 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 04 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 Patients undergoing medical checkup are also included.

Management information
Registered date
2018 Year 05 Month 13 Day
Last modified on
2018 Year 05 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037149

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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