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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025826
Receipt No. 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 2017/01/24

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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
Email 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
Email g-okada@pu-hiroshima.ac.jp

Sponsor
Institute Prefectural University of Hiroshima
Institute
Department

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
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 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 Open public recruiting
Date of protocol fixation
2016 Year 09 Month 29 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 25 Day
Last follow-up date
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
2017 Year 01 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029697

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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