UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025826 |
|---|---|
| Receipt number | R000029697 |
| Scientific Title | Availability of nutritional evaluation using CT and time-dependent changes of nutritional status in patients treated with gastrectomy |
| Date of disclosure of the study information | 2017/01/25 |
| Last modified on | 2020/01/29 13:46:56 |
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Basic information
Public title
Availability of nutritional evaluation using CT and time-dependent changes of nutritional status in patients treated with gastrectomy
Acronym
Availability of nutritional evaluation using CT and time-dependent changes of nutritional status in patients treated with gastrectomy
Scientific Title
Availability of nutritional evaluation using CT and time-dependent changes of nutritional status in patients treated with gastrectomy
Scientific Title:Acronym
Availability of nutritional evaluation using CT and time-dependent changes of nutritional status in patients treated with gastrectomy
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study is intended for patients with gastrectomy. We investigate the availability in nutritional evaluation of skeletal muscle, subcutaneous adipose tissue, and visceral adipose tissue area using the CT. We analyze the time-dependent changes in nutritional status of each surgical procedures for gastric cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skeletal muscle, subcutaneous adipose tissue, and visceral adipose tissue area using the CT.
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
Patients who diagnosed as having gastric cancer and intended to undergo gastrectomy.
Patients who signed informed consent to participate in the study.
Key exclusion criteria
Patients who cannot get the CT exam.
Patients who cannot undergo one-stage gastrectomy.
Additionally, patients who are regarded as unsuitable for this study by the investigators.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Okada Genya |
Organization
Prefectural University of Hiroshima
Division name
Department of Health Science
Zip code
Address
1-1-71 Ujina-Higashi, Minami-ku, Hiroshima
TEL
+81-8-2251-9841
g-okada@pu-hiroshima.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Okada Genya |
Organization
Prefectural University of Hiroshima
Division name
Department of Health Science
Zip code
Address
1-1-71 Ujina-Higashi, Minami-ku, Hiroshima
TEL
+81-8-2251-9841
Homepage URL
g-okada@pu-hiroshima.ac.jp
Sponsor or person
Institute
Prefectural University of Hiroshima
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Fukuyama city Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
福山市民病院（広島県）/Fukuyama city Hospital(Hiroshima)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | 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
Completed
Date of protocol fixation
| 2016 | Year | 09 | Month | 29 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 29 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is intended for patients with gastrectomy. We investigate the availability in nutritional evaluation of skeletal muscle, subcutaneous adipose tissue, and visceral adipose tissue area using the CT. We analyze the time-dependent changes in nutritional status of each surgical procedures for gastric cancer.
Management information
Registered date
| 2017 | Year | 01 | Month | 24 | Day |
Last modified on
| 2020 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029697
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
