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)

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) - WJOG13320GPS-TR

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000047338

Enrollment

900

Registered

2022-03-31

Start date

2022-05-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

unresectable advanced or recurrent gastric cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria: 1)A history of allogeneic hematopoietic stem cell transplantation or organ transplantation 2)An enrollment is judged as inappropriate by a physician.

Design outcomes

Primary

Measure	Time frame
1. Frequency of each genetic abnormality in tumor tissue 2. Frequency of serious irAEs by each gene variant in tumor tissue or peripheral blood	—

Secondary

Measure	Time frame
1. Frequency of each gene variant in tumor tissue or peripheral blood 2. Success rate of genetic analysis of tumor tissue	—

Countries

Japan

Contacts

Public ContactShinichiro Nakamura

West Japan Oncology Group WJOG datacenter

datacenter@wjog.jp06-6633-7400

Outcome results