UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053115 |
|---|---|
| Receipt number | R000060613 |
| Scientific Title | Creation and validation of age specific reference values for skeletal muscle index using preoperative CT images of gastric cancer patients undergoing surgery, and establishment of cut-off values for predicting prognosis: a multicenter retrospective study |
| Date of disclosure of the study information | 2023/12/15 |
| Last modified on | 2023/12/15 11:01:03 |
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Basic information
Public title
Creation and validation of age specific reference values for skeletal muscle index using preoperative CT images of gastric cancer patients undergoing surgery, and establishment of cut-off values for predicting prognosis: a multicenter retrospective study
Acronym
Creation of age-specific reference values for CT-derived skeletal muscle index
Scientific Title
Creation and validation of age specific reference values for skeletal muscle index using preoperative CT images of gastric cancer patients undergoing surgery, and establishment of cut-off values for predicting prognosis: a multicenter retrospective study
Scientific Title:Acronym
Preoperative SMI and PMI for gastric cancer
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To develop and validate age-specific standard and prognostic cut-off value for skeletal muscle index using preoperative CT images of gastric cancer patients.
Basic objectives2
Others
Basic objectives -Others
Create standard values
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skeletal muscle index (SMI: Skeletal muscle mass index, PMI: Psoas muscle mass index) calculated from preoperative CT images of gastric cancer
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Primary gastric cancer or esophagogastric junction cancer with histologically confirmed adenocarcinoma.
2) Gastrectomy for gastric cancer between January 2011 and December 2016.
Key exclusion criteria
1) received neo-adjuvant chemotherapy
2) no preoperative CT scan
3) Participants who desire to withdraw from the present study via opt-out.
4) Other unfeasible factors to perform study safely approved by attending surgeon.
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Kazuyoshi |
| Middle name | |
| Last name | Yamamoto |
Organization
Graduate School of Medicine, Osaka University
Division name
Department of Gastroenterological Surgery
Zip code
565-0871
Address
2-2 Yamadaoka, Suita City, Osaka
TEL
0668793251
kyamamoto13@gesurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiro |
| Middle name | |
| Last name | Yukawa |
Organization
Graduate School of Medicine, Osaka University
Division name
Department of Gastroenterological Surgery
Zip code
565-0871
Address
2-2 Yamadaoka, Suita City, Osaka
TEL
0668793251
Homepage URL
yyukawa@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Support Division, Education and Research Support Section, Osaka University School of Medicine
Address
2-2 Yamadaoka, Suita City, Osaka
Tel
06-6210-8296
rinri@hp-crc.med.osaka-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
| 2023 | Year | 12 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A multi-center retrospective study
Management information
Registered date
| 2023 | Year | 12 | Month | 15 | Day |
Last modified on
| 2023 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060613
| Research Plan | |
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| 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 |
