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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030850
Receipt No. R000035224
Scientific Title An observational study to discover novel biomarkers for nivolumab in patients with advanced gastric cancer (DELIVER trial): JACCRO GC-08
Date of disclosure of the study information 2018/01/17
Last modified on 2020/07/21

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Basic information
Public title An observational study to discover novel biomarkers for nivolumab in patients with advanced gastric cancer (DELIVER trial): JACCRO GC-08
Acronym An observational/translational study for nivolumab in gastric cancer (DELIVER trial): JACCRO GC-08
Scientific Title An observational study to discover novel biomarkers for nivolumab in patients with advanced gastric cancer (DELIVER trial): JACCRO GC-08
Scientific Title:Acronym An observational/translational study for nivolumab in gastric cancer (DELIVER trial): JACCRO GC-08
Region
Japan

Condition
Condition Gastric cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 The purpose of this study is to evaluate efficacy and safety of nivolumab treatment for advanced gastric cancer in clinical practice. The translational study also is performed to identify the predictive factors for efficacy or toxicity of nivolumab by analyzing gut microbiome, genetic polymorphism, gene expression, and metabolome in plasma before and after treatment.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Overall Survival
Key secondary outcomes Response Rate, Disease Control Rate, Depth of Response, Tumor Shrinkage Rate, Tumor Progression Rate, Progression-Free Survival, Safety, Biomarker Analysis

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) Patients with histologically confirmed diagnosis of adenocarcinoma of the GEJ/gastric cancer.
(2) Patients treated with nivolumab alone treatment (in any lines).
(3) ECOG performance status 0-2.
(4) 20 years of age or more.
(5) Patients with potential to collect feces and blood before and after nivolumab treatment.
(6) Written informed consent.
Key exclusion criteria (1) Patients previously treated with nivolumab
(2) HBs antigen-positive or HCV antibody-positive
(3) Patients who are regarded as inadequate for study enrollment by investigators.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Yu
Middle name
Last name Sunakawa
Organization St. Marianna University School of Medicine
Division name Department of Clinical Oncology
Zip code 216-8511
Address 2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511, Japan
TEL 044-977-8111
Email y.sunakawa@marianna-u.ac.jp

Public contact
Name of contact person
1st name Masashi
Middle name
Last name Fujii
Organization Japan Clinical Cancer Research Organization (JACCRO)
Division name Office
Zip code 104-0061
Address 1-14-5 Ginza, Chuo-ku, Tokyo 104-0061, Japan
TEL 03-5579-9882
Homepage URL
Email gc08.dc@jaccro.or.jp

Sponsor
Institute Japan Clinical Cancer Research Organization (JACCRO)
Institute
Department

Funding Source
Organization ONO PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor DNA Chip Research Inc.
Name of secondary funder(s) Bristol-Myers Squibb Co. Ltd.

IRB Contact (For public release)
Organization Japan Clinical Cancer Research Organization Institutional Review Board
Address 7F Ginza Wing Bil.,1-14-5 Ginza, Chuo-ku, Tokyo 104-0061, Japan
Tel 03-5579-9882
Email 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 聖マリアンナ医科大学(神奈川県)他

Other administrative information
Date of disclosure of the study information
2018 Year 01 Month 17 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 501
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
2018 Year 01 Month 15 Day
Date of IRB
2018 Year 01 Month 15 Day
Anticipated trial start date
2018 Year 03 Month 01 Day
Last follow-up date
2022 Year 08 Month 31 Day
Date of closure to data entry
2022 Year 08 Month 31 Day
Date trial data considered complete
2022 Year 12 Month 31 Day
Date analysis concluded
2023 Year 03 Month 31 Day

Other
Other related information prospective observational study.
We research about patient backgrounds, treatment, safety and efficacy.

Management information
Registered date
2018 Year 01 Month 17 Day
Last modified on
2020 Year 07 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035224

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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