UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061288 |
|---|---|
| Receipt number | R000070124 |
| Scientific Title | Development and External Validation of Machine Learning Models for Predicting Postoperative Recurrence in Gastric Cancer: A TRIPOD+AI-Compliant Single-Center Cohort Study |
| Date of disclosure of the study information | 2026/05/01 |
| Last modified on | 2026/04/17 12:59:01 |
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Basic information
Public title
Development and External Validation of Machine Learning Models for Predicting Postoperative Recurrence in Gastric Cancer: A TRIPOD+AI-Compliant Single-Center Cohort Study
Acronym
ML Models for Gastric Cancer Recurrence
Scientific Title
Development and External Validation of Machine Learning Models for Predicting Postoperative Recurrence in Gastric Cancer: A TRIPOD+AI-Compliant Single-Center Cohort Study
Scientific Title:Acronym
ML Models for Gastric Cancer Recurrence
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aims of this study were to: (1) develop ML models for postoperative gastric cancer recurrence in a Japanese single-center curative resection cohort using multivariate iterative imputation; (2) evaluate external generalizability in an independent holdout cohort; (3) improve probability calibration via post-hoc sigmoid calibration; (4) quantify clinical utility using bootstrap-corrected DCA; and (5) assess model interpretability using SHAP values.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Discrimination is assessed by ROC-AUC and precision-recall AUC. Clinical utility is evaluated by DCA.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Age is greater than or equal to 20 years
Histologically confirmed gastric adenocarcinoma
Underwent curative (R0) gastrectomy (total, distal, or proximal gastrectomy with lymph node dissection)
Surgery performed between April 2008 and March 2020 at the study institution
Follow-up duration of at least 3 months
Key exclusion criteria
Presence of concurrent non-gastric malignancies
Receipt of neoadjuvant chemotherapy or chemoradiotherapy
Emergency surgery or reduced-function procedures
Follow-up duration of less than 3 months
Target sample size
1162
Research contact person
Name of lead principal investigator
| 1st name | Goshi |
| Middle name | |
| Last name | Fujimoto |
Organization
Kameda Medical Center
Division name
Gastroenterological Surgery
Zip code
296-0041
Address
929 Higashi-cho, Kamogawa City, Chiba Prefecture 296-8602, Japan
TEL
0470922211
g_chimera_7@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Goshi |
| Middle name | |
| Last name | Fujimoto |
Organization
Kameda Medical Center
Division name
Gastroenterological Surgery
Zip code
296-0041
Address
929 Higashi-cho, Kamogawa City, Chiba Prefecture 296-8602, Japan
TEL
0470922211
Homepage URL
g_chimera_7@yahoo.co.jp
Sponsor or person
Institute
Kameda Medical Center
Institute
Department
Personal name
Goshi Fujimoto
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kameda Medical Center
Address
929 Higashi-cho, Kamogawa City, Chiba Prefecture 296-8602, Japan
Tel
0470922211
g_chimera_7@yahoo.co.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
静岡県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 04 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 04 | Month | 25 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a single-center retrospective observational study. Using routinely collected clinical data from medical records, we develop machine learning based prediction models to estimate postoperative recurrence risk after curative resection for gastric cancer and to evaluate their external validity.
This study involves no intervention. All analyses are conducted using existing data obtained as part of standard clinical care, and no changes are made to treatment strategies, follow-up schedules, examinations, or outcome assessments for research purposes.
The study period is temporally divided into a development cohort and an independent external validation cohort (temporal validation design). The primary outcome is postoperative recurrence, defined as recurrence confirmed by imaging studies and/or histopathological diagnosis.
Management information
Registered date
| 2026 | Year | 04 | Month | 17 | Day |
Last modified on
| 2026 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070124
