UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047338 |
|---|---|
| Receipt number | R000053989 |
| Scientific Title | An exploratory study of genomic profiling according to microsatellite instability status and genetic variants associated with immune-related adverse events in unresectable or recurrent gastric cancer (WJOG13320GPS-TR) |
| Date of disclosure of the study information | 2022/03/31 |
| Last modified on | 2024/10/01 09:22:15 |
* 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
An exploratory study of genomic profiling according to microsatellite instability status and genetic variants associated with immune-related adverse events in unresectable or recurrent gastric cancer (WJOG13320GPS-TR)
Acronym
WJOG13320GPS-TR
Scientific Title
An exploratory study of genomic profiling according to microsatellite instability status and genetic variants associated with immune-related adverse events in unresectable or recurrent gastric cancer (WJOG13320GPS-TR)
Scientific Title:Acronym
WJOG13320GPS-TR
Region
| Japan |
Condition
Condition
unresectable advanced or recurrent gastric cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To explore genomic profiling according to microsatellite instability status and genetic variants associated with immune-related adverse events in patients with unresectable or recurrent gastric cancer enrolled in WJOG13320GPS study
Basic objectives2
Others
Basic objectives -Others
1) Using genetic abnormality information from gastric cancer tumor tissues, we explore the association between microsatellite instability status and other genetic abnormality profiles.
2) To explore genetic variants associated with the development of immune-related adverse events (irAEs) caused by immune checkpoint inhibitors.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Frequency of each genetic
abnormality in tumor tissue
2. Frequency of serious irAEs by each gene variant in tumor tissue or peripheral blood
Key secondary outcomes
1. Frequency of each gene variant in tumor tissue or peripheral blood
2. Success rate of genetic analysis of tumor tissue
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
1)Participating in the WJOG13320GPS study.
2)Formalin fixed and paraffin embedded (FFPE) sections containing tumor tissue and a peripheral blood sample can be provided.
3)Written consent for participation in this study has been obtained from the patient after a sufficient explanation of the study contents, including germ line gene analysis, has been given.
Key exclusion criteria
1)A history of allogeneic hematopoietic stem cell transplantation or organ transplantation
2)An enrollment is judged as inappropriate by a physician.
Target sample size
900
Research contact person
Name of lead principal investigator
| 1st name | Hidekazu |
| Middle name | |
| Last name | Hirano |
Organization
National Cancer Center Hospital
Division name
Department of Gastrointestinal Medical Oncology
Zip code
104-0045
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045, JAPAN
TEL
03-3542-2511
hihirano@ncc.go.jp
Public contact
Name of contact person
| 1st name | Shinichiro |
| Middle name | |
| Last name | Nakamura |
Organization
West Japan Oncology Group
Division name
WJOG datacenter
Zip code
556-0016
Address
Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka 556-0016 JAPAN
TEL
06-6633-7400
Homepage URL
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
Institute
Department
Personal name
Funding Source
Organization
SYSMEX CORPORATION
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National cancer Center Institutional Review Board
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, JAPAN
Tel
03-3542-2511
NCC_IRBoffice@ml.res.ncc.go.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 | 03 | Month | 31 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 05 | Month | 29 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1) Using genetic abnormality information from gastric cancer tumor tissues, we explore the association between microsatellite instability status and other genetic abnormality profiles.
2) To explore genetic variants associated with the development of immune-related adverse events (irAEs) caused by immune checkpoint inhibitors.
Management information
Registered date
| 2022 | Year | 03 | Month | 31 | Day |
Last modified on
| 2024 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053989
