UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032577 |
|---|---|
| Receipt number | 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 | 2023/06/16 21:30:28 |
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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 | Yukihiro |
| Middle name | |
| Last name | Yokoyama |
Organization
Nagoya University Graduate School of Medicine
Division name
Division of Surgical Oncology, Department of Surgery
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
+81527442222
yyoko@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Yukihiro |
| Middle name | |
| Last name | Yokoyama |
Organization
Nagoya University Graduate School of Medicine
Division name
Division of Surgical Oncology, Department of Surgery
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
+81527442222
Homepage URL
yyoko@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
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
Human Research Review Committee of Nagoya University Hospital
Address
65
Tel
0527442479
ethics@med.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
| 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
Completed
Date of protocol fixation
| 2018 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 30 | Day |
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
| 2023 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037149
