UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058593 |
|---|---|
| Receipt number | R000064871 |
| Scientific Title | Prospective Observational Study to Validate HER2 Detection Rates in Advanced Gastric Cancer |
| Date of disclosure of the study information | 2025/07/25 |
| Last modified on | 2025/07/25 07:46:59 |
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Basic information
Public title
Prospective Observational Study to Validate HER2 Detection Rates in Advanced Gastric Cancer
Acronym
Prospective Observational Study to Validate HER2 Detection Rates in Advanced Gastric Cancer
Scientific Title
Prospective Observational Study to Validate HER2 Detection Rates in Advanced Gastric Cancer
Scientific Title:Acronym
Prospective Observational Study to Validate HER2 Detection Rates in Advanced Gastric Cancer
Region
| Japan |
Condition
Condition
Advanced gastric cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the concordance rate of HER2 positivity between HER2 positivity in patients undergoing endoscopic biopsy of advanced gastric cancer
Basic objectives2
Others
Basic objectives -Others
Positive rates of HER2 and CLDN18.2 in upper gastrointestinal endoscopy
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HER2 concordance rate between surgical and biopsy specimens in patients undergoing surgery excluding neoadjuvant chemotherapy and conversion surgery
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Endoscopic biopsy of a tumor suspected of advanced gastric cancer or diagnosed as advanced gastric cancer
Key exclusion criteria
1.Biopsy at another hospital confirms a histopathological type other than adenocarcinoma.
2.Patients who are at high risk of bleeding or who are unable to withdraw antithrombotic drugs according to Criteria for Withdrawal of Antithrombotic Drugs in Gastrointestinal Endoscopy Practice.
3.Other patients deemed inappropriate for inclusion by the study investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Chika |
| Middle name | |
| Last name | Kusano |
Organization
Kitasato University, school of medicine
Division name
Department of gastroenterology
Zip code
2520374
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
TEL
0427788111
c-kusano@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | TAKUYA |
| Middle name | |
| Last name | WADA |
Organization
Kitasato University, school of medicine
Division name
Department of gastroenterology
Zip code
2520374
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
TEL
0427788111
Homepage URL
t.wada@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato university, school of medicine
Institute
Department
Personal name
Funding Source
Organization
Kitasato university
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
Kitasato university, school of medicine
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
Tel
0427788111
t.wada@kitasato-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
北里大学病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 25 | 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 | 05 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 07 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2029 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational cross-sectional study
Management information
Registered date
| 2025 | Year | 07 | Month | 25 | Day |
Last modified on
| 2025 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064871
