UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043051 |
|---|---|
| Receipt number | R000049147 |
| Scientific Title | Biomarker study of soluble immune factors using plasma samples obtained in the JACCRO GC-08 study |
| Date of disclosure of the study information | 2021/01/20 |
| Last modified on | 2021/01/18 22:57:40 |
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Basic information
Public title
A study using plasma samples obtained in the JACCRO GC-08 study
Acronym
JACCRO GC-08AR
Scientific Title
Biomarker study of soluble immune factors using plasma samples obtained in the JACCRO GC-08 study
Scientific Title:Acronym
JACCRO GC-08AR
Region
| Japan |
Condition
Condition
Gastric Cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We will measure soluble immune factors (soluble PD-L1, soluble PD-1, soluble CTLA-4) using residual plasma samples from the "Observational study including biomarker discovery of nivolumab in patients with unresectable advanced gastric cancer (DELIVER study): JACCRO GC-08" and evaluate the distribution of the measured values and their relationship with clinical data.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between soluble PD-L1, soluble PD-1, and soluble CTLA-4 before nivolumab treatment and progression-free survival in patients with unresectable advanced gastric cancer
Key secondary outcomes
Relationship between soluble PD-L1, soluble PD-1, and soluble CTLA-4 and efficacy (overall survival, response rate, hyper progressive disease) and safety before nivolumab treatment in patients with unresectable advanced gastric cancer
Relationship between soluble PD-L1, soluble PD-1, and soluble CTLA-4 and clinical background factors
Relationship between soluble PD-L1, soluble PD-1, and soluble CTLA-4 and efficacy (progression-free survival, overall survival,
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
Patients who participated in the "Observational Study Including Biomarker Discovery of Nivolumab in Patients with Unresectable Advanced Gastric Cancer (DELIVER Study): JACCRO GC-08" and were able to submit a 500uL plasma sample prior to nivolumab treatment.
Key exclusion criteria
Patients who declined to participate in the "Observational Study of Nivolumab in Unresectable Advanced Gastric Cancer with Biomarker Discovery in Patients with Advanced Unresectable Gastric Cancer (DELIVER): JACCRO GC-08".
Target sample size
501
Research contact person
Name of lead principal investigator
| 1st name | Hisato |
| Middle name | |
| Last name | KAWAKAMI |
Organization
Kindai University Faculty of Medicine
Division name
Department of Medical Oncology
Zip code
589-8511
Address
377-2, Ohno-higashi, Osakasayama, Osaka, Japan
TEL
+81-72-366-0221
kawakami_h@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Hisato |
| Middle name | |
| Last name | KAWAKAMI |
Organization
Kindai University Faculty of Medicine
Division name
Department of Medical Oncology
Zip code
589-8511
Address
377-2, Ohno-higashi, Osakasayama, Osaka, Japan
TEL
+81-72-366-0221
Homepage URL
kawakami_h@med.kindai.ac.jp
Sponsor or person
Institute
Japan Clinical Cancer Research Organization (JACCRO)
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
Department of Medical Oncology, Kindai University Faculty of Medicine; Department of Genome Biology, Kindai University Faculty of Medicine; Department of Immunology and Genomic Medicine, and Center for Cancer Immunotherapy and Immunobiology (CCII), Kyoto University Graduate School of Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Clinical Cancer Research Organization (JACCRO)
Address
6F Jimbocho Kyowa Bldg. 1-64 Kanda-Jimbocho, Chiyoda-ku, Tokyo, Japan
Tel
03-6811-0433
irb-jaccro@jaccro.or.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
近畿大学病院（大阪府）他
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 01 | Month | 20 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 12 | Month | 14 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 14 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 14 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 15 | Day |
Date of closure to data entry
| 2021 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 31 | Day |
Other
Other related information
Relationship between soluble PD-L1, soluble PD-1, and soluble CTLA-4 and efficacy (overall survival, response rate, hyper progressive disease) and safety before nivolumab treatment in patients with unresectable advanced gastric cancer
Relationship between soluble PD-L1, soluble PD-1, and soluble CTLA-4 and clinical background factors
Relationship between soluble PD-L1, soluble PD-1, and soluble CTLA-4 and efficacy (progression-free survival, overall survival, response rate, and hyper progressive disease) and safety after nivolumab treatment in patients with unresectable advanced gastric cancer
Association with other biomarkers obtained in the JACCRO GC-08 study
Translated with www.DeepL.com/Translator (free version)
Management information
Registered date
| 2021 | Year | 01 | Month | 18 | Day |
Last modified on
| 2021 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049147
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