UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046593 |
|---|---|
| Receipt number | R000053152 |
| Scientific Title | Clinical relivance of immunoscore in gastric cancer |
| Date of disclosure of the study information | 2022/01/09 |
| Last modified on | 2022/01/09 17:12:51 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Clinical relivance of immunoscore in gastric cancer
Acronym
Clinical relivance of immunoscore in gastric cancer
Scientific Title
Clinical relivance of immunoscore in gastric cancer
Scientific Title:Acronym
Clinical relivance of immunoscore in gastric cancer
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The density of tumor infiltrating immune cells (CD3, CD8, CD45RO, etc.) and the expression rate of other biomarkers will be examined using specimens from gastric cancer cases surgically resected between January 1, 2008 and December 31, 2010 at affiliated institutions. We will also examine the relationship between the expression of these markers and prognosis by histological type and stage.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage expression of tumor infiltrating immune cells (CD3, CD8, CD45RO, etc.)
Key secondary outcomes
1, Relationship between the expression rate of tumor-infiltrating immune cells (CD3, CD8, CD45RO, etc.) and prognosis and chemotherapy response
2, Expression rate of immune checkpoint molecules (PD-L1, PD-L2, PD-1, TIM-3, CTLA-4, ICOS, LAG3, etc.) and mismatch repair genes (MLH1, MSH2, MSH6, PMS2)
3, Association between the expression rate of tumor-infiltrating immune cells (CD3, CD8, CD45RO, etc.) and the expression rate of immune checkpoint molecules (PD-L1, PD-L2, PD-1, TIM-3, CTLA-4, ICOS, LAG3, etc.) and mismatch repair genes (MLH1, MSH2, MSH6, PMS2)
4, Association between expression rates of immune checkpoint molecules (PD-L1, PD-L2, PD-1, TIM-3, CTLA-4, ICOS, LAG3, etc.) and mismatch repair genes (MLH1, MSH2, MSH6, PMS2) and prognosis and chemotherapy response
Translated with www.DeepL.com/Translator (free version)
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
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who are diagnosed as gastric cancer which are proven by biopsy as adenocarinoma and can receive radical resection.
Key exclusion criteria
Synchronous or metachronous (within 5 years) malignancies
Target sample size
1000
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
565-0871
Address
2-2 Yamadaoka, Suita city, Osaka, Japan
TEL
0668793251
tsaito@gesurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Takuro |
| Middle name | |
| Last name | Saito |
Organization
Osaka University Clinical Research Group for Gastroenterological Study
Division name
Osaka University Clinical Research Group for Gastroenterological Study
Zip code
565-0871
Address
2-2 Yamadaoka, Suita city, Osaka, Japan
TEL
06-6879-3251
Homepage URL
tsaito@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Clinical Research Group for Gastroenterological Study
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
Academic Clinical Research Center of Osaka University Hospital
Address
2-2 Yamadaoka, Suita city, Osaka, Japan
Tel
06-6210-8290
acr-jim@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
| 2022 | Year | 01 | Month | 09 | 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
| 2021 | Year | 12 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 12 | Month | 07 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
not yet
Management information
Registered date
| 2022 | Year | 01 | Month | 09 | Day |
Last modified on
| 2022 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053152
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
