UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041858 |
|---|---|
| Receipt number | R000047787 |
| Scientific Title | Nutritional status of postoperative patients with gastric cancer |
| Date of disclosure of the study information | 2020/09/25 |
| Last modified on | 2020/09/22 08:30:53 |
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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
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
kaida@belle.shiga-med.ac.jp
Sponsor or person
Institute
Department of Surgery, Shiga University of Medical Science
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047787
