UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061623 |
|---|---|
| Receipt number | R000070503 |
| Scientific Title | Observational Study of HER2 Expression in Surgical Specimens of Gastric Cancer |
| Date of disclosure of the study information | 2026/05/19 |
| Last modified on | 2026/05/19 09:01:00 |
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Basic information
Public title
Observational Study of HER2 Expression in Surgical Specimens of Gastric Cancer
Acronym
Observational Study of HER2 Expression in Surgical Specimens of Gastric Cancer
Scientific Title
Observational Study of HER2 Expression in Surgical Specimens of Gastric Cancer
Scientific Title:Acronym
Observational Study of HER2 Expression in Surgical Specimens of Gastric Cancer
Region
| Japan |
Condition
Condition
Gastric and Esophagogastric Junction Adenocarcinoma
Classification by specialty
| Hematology and clinical oncology | Surgery in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the impact of reducing the time required for specimen processing and increasing the number of pathological evaluation sections on HER2 diagnosis in surgical specimens of gastric cancer.
Basic objectives2
Others
Basic objectives -Others
Not applicable
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
HER2 positivity rate
Key secondary outcomes
Overall survival in patients with recurrence or non-curative resection
Relapse-free survival
Treatment details and treatment efficacy
Association between warm ischemic time, cold ischemic time, formalin fixation time, and biomarker positivity rates
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients scheduled to undergo gastrectomy for gastric cancer.
Histologically diagnosed adenocarcinoma (conventional type or lymphocyte-rich carcinoma).
Preoperatively diagnosed as cT2 or deeper according to the Japanese Classification of Gastric Carcinoma, 15th edition.
Age over 18 years at the time of enrollment.
Written informed consent for study participation has been obtained from the patient.
Key exclusion criteria
History of preoperative chemotherapy or radiotherapy for gastric cancer.
Patients deemed inappropriate for participation by the investigator.
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Yoshitomo |
| Middle name | |
| Last name | Yanagimoto |
Organization
Osaka International Cancer Institute
Division name
Department of Gastroenterological Surgery
Zip code
541-8567
Address
3-1-69, Otemae, Chuo-ku, Osaka, Japan
TEL
06-6945-1181
yoshitomo-0225@outlook.com
Public contact
Name of contact person
| 1st name | Yoshitomo |
| Middle name | |
| Last name | Yanagimoto |
Organization
Osaka International Cancer Institute
Division name
Department of Gastroenterological Surgery
Zip code
587-0052
Address
3-1-69, Otemae, Chuo-ku, Osaka, Japan
TEL
06-6945-1181
Homepage URL
yoshitomo-0225@outlook.com
Sponsor or person
Institute
Osaka International Cancer Institute
Institute
Department
Personal name
Yoshitomo Yanagimoto
Funding Source
Organization
Not applicable
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
Osaka International Cancer Institute
Address
3-1-69, Otemae, Chuo-ku, Osaka, Japan
Tel
06-6945-1181
rinri01@opho.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
大阪府
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 19 | 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
| 2025 | Year | 06 | Month | 09 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 03 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 13 | Day |
Last follow-up date
| 2033 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
_
Management information
Registered date
| 2026 | Year | 05 | Month | 19 | Day |
Last modified on
| 2026 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070503
