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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034836
Receipt No. R000039728
Scientific Title A multi-center retrospective observational study to evaluate PD-L1 protein expression, EBV positivity and the frequency of MSI-H in patients with advanced gastric and esophagogastric junction adenocarcinoma in Japan
Date of disclosure of the study information 2018/11/12
Last modified on 2019/05/16

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Basic information
Public title A multi-center retrospective observational study to evaluate PD-L1 protein expression, EBV positivity and the frequency of MSI-H in patients with advanced gastric and esophagogastric junction adenocarcinoma in Japan
Acronym A multi-center retrospective observational study to evaluate PD-L1 protein expression, EBV positivity and the frequency of MSI-H in patients with advanced gastric and esophagogastric junction adenocarcinoma in Japan
Scientific Title A multi-center retrospective observational study to evaluate PD-L1 protein expression, EBV positivity and the frequency of MSI-H in patients with advanced gastric and esophagogastric junction adenocarcinoma in Japan
Scientific Title:Acronym A multi-center retrospective observational study to evaluate PD-L1 protein expression, EBV positivity and the frequency of MSI-H in patients with advanced gastric and esophagogastric junction adenocarcinoma in Japan
Region
Japan

Condition
Condition advanced gastric and esophagogastric junction adenocarcinoma
Classification by specialty
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 In clinical studies of pembrolizumab in advanced gastric and esophagogastric junction adenocarcinoma, PD-L1 expression has been evaluated by the Combined Positive Score (CPS) scoring method using the 22C3 antibody. There is no relevant data that examined the PD-L1 protein expression in Japanese population with the same method
Basic objectives2 Others
Basic objectives -Others Molecular epidemiology study
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes PD-L1 expression (evaluation by the CPS) measured by PD-L1 IHC 22C3 pharmDx kit; EBV positivity; and Microsatellite instability frequency.
Key secondary outcomes To characterize association between PD-L1 expression and other molecular biological factors (HER2 expression and H. pylori infection) in Japanese patients with advanced gastric and esophagogastric junction adenocarcinoma.

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) Japanese patients with advanced gastric and esophagogastric junction adenocarcinoma who were diagnosed with pStage II or III after surgical resection in or after 2014 and experienced recurrence at or after 6 months after postoperative adjuvant chemotherapy; or who were diagnosed with unresectable advanced cancer (Stage IV) and underwent tumor sampling in or after 2014
2) Patients with archived tumor samples from which 14 paraffin sections can be obtained
3) Patients aged at least 20 years at the time of sampling
4) Patients who give written consents for participation in this study by themselves, in principle, or by legally acceptable representatives
Key exclusion criteria 1) Patients with other primary tumor types at the time the tissue sample was collected
2) Patients who had underwent radiation therapy before tumor sampling
3) Patients who had received systemic chemotherapy before tumor sampling
4) Patients with tumor samples that were obtained before 2014
5) Patients with tumor tissues that were thinly sliced more than 6 months ago
6) Patients with less than 100 tumor cells available
7) Patients whose samples are considered to be in an extremely poor preservation condition by the investigators
8) Other patients whose enrollment in the study is considered inappropriate by the investigators
Target sample size 400

Research contact person
Name of lead principal investigator
1st name Akiko
Middle name
Last name Shimizu
Organization MSD K.K.
Division name oncology medical affairs
Zip code 102-8667
Address 1-13-12 Kudan-kita, Chiyoda-ku, Tokyo
TEL 03-6372-0665
Email ldgproject@merck.com

Public contact
Name of contact person
1st name Iida
Middle name
Last name Fumiyuki
Organization EP Cruise Co.,Ltd.
Division name Project promotion department
Zip code 160-0023
Address KDX Shinjuku Bldg. 9F 3-2-7 Nishi-Shinjuku, Shinjuku-ku, Tokyo
TEL 03-6901-6079
Homepage URL
Email PD-L1@sogo-medefi.jp

Sponsor
Institute Profit organization
Institute
Department

Funding Source
Organization Profit organization
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethic Committee
Address 840 Shijo-cho, Kashihara, Nara JAPAN
Tel 0744-22-3051
Email ino_rinri@naramed-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
2018 Year 11 Month 12 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 Preinitiation
Date of protocol fixation
2018 Year 03 Month 27 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information multicenter reterospective observational study

Management information
Registered date
2018 Year 11 Month 09 Day
Last modified on
2019 Year 05 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039728

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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