UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063060 |
|---|---|
| Receipt number | R000072190 |
| Scientific Title | Development and Validation of a pT2N0-Exclusion Score to Aid Selection of Perioperative Chemotherapy (D-FLOT) Candidates in Gastric Cancer with Borderline Staging on Diagnostic Imaging |
| Date of disclosure of the study information | 2026/09/26 |
| Last modified on | 2026/09/26 12:57:22 |
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Basic information
Public title
Development and Validation of a pT2N0-Exclusion Score to Aid Selection of Perioperative Chemotherapy (D-FLOT) Candidates in Gastric Cancer with Borderline Staging on Diagnostic Imaging
Acronym
pT2N0-Exclusion Score for D-FLOT
Scientific Title
Development and Validation of a pT2N0-Exclusion Score to Aid Selection of Perioperative Chemotherapy (D-FLOT) Candidates in Gastric Cancer with Borderline Staging on Diagnostic Imaging
Scientific Title:Acronym
pT2N0-Exclusion Score for D-FLOT
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 a statistical scoring system, based solely on preoperatively available information, for predicting the likelihood of pathological T2N0 gastric cancer, and to assess its discrimination, calibration, and clinical utility.
Basic objectives2
Others
Basic objectives -Others
Diagnosis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Discrimination (area under the receiver operating characteristic curve [AUC], including bootstrap optimism-corrected estimates) of the developed pT2N0-exclusion score.
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
Patients who underwent gastrectomy for gastric cancer at our department of gastroenterological surgery between April 1, 2000, and March 31, 2026, with pathological T factor of T2 or T3 and pathological N factor of N0 or N1.
Key exclusion criteria
Patients meeting any of the following criteria were excluded: (1) receipt of neoadjuvant chemotherapy; (2) positive peritoneal cytology or seeding; (3) distant metastasis (M1); (4) R2 resection; (5) special histological type, including neuroendocrine carcinoma.
Target sample size
469
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
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 26 | 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
469
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
No longer recruiting
Date of protocol fixation
| 2026 | Year | 09 | Month | 17 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 17 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single-center retrospective observational study conducted at the Department of Gastroenterological Surgery, Kameda Medical Center, using only pre-existing clinical information recorded in medical records and the institutional gastric cancer database. No additional tests, treatments, or invasive procedures are performed for the purposes of this study.
Given the retrospective nature of the study, obtaining individual informed consent from each patient is not feasible; an opt-out method is therefore used, whereby information about the study is publicly disclosed and patients are given the opportunity to decline participation.
Management information
Registered date
| 2026 | Year | 09 | Month | 26 | Day |
Last modified on
| 2026 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072190
