UMIN-CTR Clinical Trial

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
Email	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
Email	tsaito@gesurg.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University Clinical Research Group for Gastroenterological Study
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053152