UMIN-CTR Clinical Trial

Basic information
Public title	Nutritional status of postoperative patients with gastric cancer
Acronym	Nutritional status of postoperative patients with gastric cancer
Scientific Title	Nutritional status of postoperative patients with gastric cancer
Scientific Title:Acronym	Nutritional status of postoperative patients with gastric cancer
Region	Japan

Condition
Condition	Gastric cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate and study the nutritional status of patients with gastric cancer after gastrectomy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Post-operative weight loss rate in gastric cancer patients
Key secondary outcomes	Calculation of visceral fat, subcutaneous fat, abdominal circumference, and area and volume of the psoas muscle by preoperative CT in patients with gastric cancer and evaluation of the rate of reduction. The rate of change of CT values within the psoas muscle preoperatively and postoperatively.

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	1) 20 year over. 2) Histologically diagnosed with gastric cancer. 3) Resectability of R0.
Key exclusion criteria	1) Patients who do not have preoperative and postoperative CT data. 2) Patients who are unable to give consent to participate in the study.
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Sachiko Middle name Last name Kaida
Organization	Shiga University of Medical Science
Division name	Department of Surgery
Zip code	520-2192
Address	Tsukinowa-cho, Seta, Otsu, Shiga
TEL	077-548-2238
Email	kaida@belle.shiga-med.ac.jp

Public contact
Name of contact person	1st name Sachiko Middle name Last name Kaida
Organization	Shiga University of Medical Science
Division name	Department of Surgery
Zip code	520-2192
Address	Tsukinowa-cho, Seta, Otsu, Shiga
TEL	077-548-2238
Homepage URL
Email	kaida@belle.shiga-med.ac.jp

Sponsor
Institute	Department of Surgery, Shiga University of Medical Science
Institute
Department

Funding Source
Organization	Department of Surgery, Shiga University of Medical Science
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Shiga University of Medical Science
Address	Tsukinowa-cho, Seta, Otsu, Shiga
Tel	077-548-2238
Email	kaida@belle.shiga-med.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	滋賀医科大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2020 Year 09 Month 25 Day

Related information
URL releasing protocol	http://www.shiga-med.ac.jp/~hqsurge1/pg288.html#rinnsyokenkyu
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 08 Month 16 Day
Date of IRB	2018 Year 08 Month 16 Day
Anticipated trial start date	2018 Year 08 Month 16 Day
Last follow-up date	2026 Year 12 Month 31 Day
Date of closure to data entry	2026 Year 12 Month 31 Day
Date trial data considered complete	2026 Year 12 Month 31 Day
Date analysis concluded	2027 Year 03 Month 31 Day

Other

Other related information

An observational study using existing materials. The following information will be collected and measured. 1) Preoperative status (age, gender, weight, BMI, preoperative stage, preoperative blood sampling to assess nutritional status, preoperative CT to measure subcutaneous fat volume, visceral fat volume, psoas muscle mass, and abdominal circumference). 2) Surgical outcomes (approach, operative time, blood loss, etc.) 3) Short-term post-operative outcomes (post-operative complications, length of hospital stay, and final stage of illness) 4) Long-term prognosis (recurrence or not, measurement of subcutaneous fat volume, visceral fat volume, psoas muscle volume and abdominal circumference by CT scan 1-5 years after surgery)

Management information
Registered date	2020 Year 09 Month 22 Day
Last modified on	2020 Year 09 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047787