UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047448 |
|---|---|
| Receipt number | R000053076 |
| Scientific Title | Exploration of biomarkers to predict the efficacy of immune checkpoint inhibitors in gastric cancer using cell-free RNA. |
| Date of disclosure of the study information | 2022/04/10 |
| Last modified on | 2025/11/27 20:14:26 |
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Basic information
Public title
Exploration of biomarkers to predict the efficacy of immune checkpoint inhibitors in gastric cancer using cell-free RNA.
Acronym
Exploration of biomarkers to predict the efficacy of immune checkpoint inhibitors in gastric cancer using cell-free RNA.
Scientific Title
Exploration of biomarkers to predict the efficacy of immune checkpoint inhibitors in gastric cancer using cell-free RNA.
Scientific Title:Acronym
Exploration of biomarkers to predict the efficacy of immune checkpoint inhibitors in gastric cancer using cell-free RNA.
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To explore biomarkers for predicting the response of nivolumab in gastric cancer.
Basic objectives2
Others
Basic objectives -Others
Exploration of biomarkers
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To explore biomarkers for predicting the response of nivolumab in gastric cancer.
Key secondary outcomes
Association of peripheral blood cfRNA with progression-free survival (PFS)
Association of Peripheral Blood cfRNA with Overall Survival (OS)
Association of Adverse Events (AEs) with cfRNA in Peripheral Blood
Time to treatment success (TTF) in relation to peripheral blood cfRNA
Disease Control Rate (DCR) and Peripheral Blood cfRNA
Association between quality of life and peripheral blood cfRNA
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants of VOYAGER study
(jRCTs071190025)
Key exclusion criteria
Inappropriate participants
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | Eiji |
| Middle name | |
| Last name | Oki |
Organization
Kyushu University Hospital
Division name
Department of Surgery and Science
Zip code
8128582
Address
Maidashi 3-1-1, Higashi-ku, Fukuoka city.
TEL
092-642-5466
oki.eiji.857@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Qingjiang |
| Middle name | |
| Last name | Hu |
Organization
Kyushu University Hospital
Division name
Department of Surgery and Science
Zip code
8128582
Address
Maidashi 3-1-1, Higashi-ku, Fukuoka city.
TEL
092-642-5466
Homepage URL
hu.qingjiang.714@m.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Hospital, Department of Surgery and Science
Institute
Department
Personal name
Funding Source
Organization
Hirose foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Center for Clinical and Translational Research, Kyushu University hospital
Address
Maidashi 3-1-1, Higashi-ku, Fukuoka city.
Tel
0926425774
ijkseimei@jimu.kyushu-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 | 04 | Month | 10 | 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
Completed
Date of protocol fixation
| 2022 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2022 | Year | 04 | Month | 09 | Day |
Last modified on
| 2025 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053076
