UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056497 |
|---|---|
| Receipt number | R000064562 |
| Scientific Title | Function analysis of the intraperitoneal and peritoneal pre-metastatic niche in peritoneal dissemination of gastric cancer. |
| Date of disclosure of the study information | 2025/01/01 |
| Last modified on | 2025/12/27 11:01:45 |
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Basic information
Public title
Function analysis of the intraperitoneal and peritoneal pre-metastatic niche in peritoneal dissemination of gastric cancer.
Acronym
Analysis of the peritoneum pre-metastatic niche of gastric cancer
Scientific Title
Function analysis of the intraperitoneal and peritoneal pre-metastatic niche in peritoneal dissemination of gastric cancer.
Scientific Title:Acronym
Analysis of the peritoneum pre-metastatic niche of gastric cancer
Region
| Japan |
Condition
Condition
Peritoneal dissemination of gastric cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To clarify the changes in the intra-abdominal and peritoneal microenvironment before peritoneal metastasis of gastric cancer
Basic objectives2
Others
Basic objectives -Others
Education of pathogenesis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Microenvironmental changes in the normal peritoneum with and without peritoneal dissemination
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who have given written consent to participate in the study
Patients who were at least 20 years old at the time of consent
Key exclusion criteria
Patients who require emergency tumor resection due to bleeding, stenosis or perforation caused by tumors
Patients with residual stomach cancer
Pregnant or lactating patients
Patients with severe liver or kidney dysfunction
Patients who are judged to be lacking the capacity to consent
Other patients who are judged to be unsuitable by the principal investigator or sub-investigators
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yuichiro |
| Middle name | |
| Last name | Doki |
Organization
Osaka University, Graduate school of Medicine
Division name
Department of Gastroenterological surgery
Zip code
5650871
Address
2-15 Yamadaoka, Suita-shi, Osaka, Japan
TEL
06-6879-5111
ydoki@gesurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Rennosuke |
| Middle name | |
| Last name | Nakamoto |
Organization
Osaka University, Graduate school of Medicine
Division name
Department of Gastroenterological surgery
Zip code
5650871
Address
2-15 Yamadaoka, Suita-shi, Osaka, Japan
TEL
06-6879-5111
Homepage URL
rnakamoto@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Osaka University Hospital
Address
2-2 Yamadaoka, Suita-shi, Osaka, Japan
Tel
06-6210-8290
jim-chiken@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
| 2025 | Year | 01 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 12 | Month | 24 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 25 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Microenvironmental changes in the normal peritoneum with and without peritoneal dissemination
Differences in the microenvironment in the peritoneal dissemination nodule and the surrounding normal peritoneum in cases of peritoneal dissemination
Prognostic analysis based on microenvironmental differences
Management information
Registered date
| 2024 | Year | 12 | Month | 19 | Day |
Last modified on
| 2025 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064562
