UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034836 |
|---|---|
| Receipt number | 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 | 2022/03/07 21:57:11 |
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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
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
PD-L1@sogo-medefi.jp
Sponsor or person
Institute
Profit organization
Institute
Department
Personal name
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
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
https://www.tandfonline.com/doi/full/10.1080/15384047.2022.2038002
Publication of results
Published
Result
URL related to results and publications
https://www.tandfonline.com/doi/full/10.1080/15384047.2022.2038002
Number of participants that the trial has enrolled
391
Results
241/389 (62%) were PD-L1 positive, 24/379 (6.3%) had MSI-H tumors, and 13/389 (3.3%) were EBV positive. Among patients with MSI-H tumors and EBV-positive tumors, 19/24 (79.2%) and 9/13 (69.2%), respectively, were PD-L1 positive. A greater proportion of patients with MSI-H tumors (83.3% [20/24]) were PD-L1 positive than those with MSI-low/stable tumors (60.8% [216/355]; p = .0297)
Results date posted
| 2022 | Year | 03 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The study enrolled Japanese patients aged over 20 years (at sampling) with Stage II or III advanced gastric and GEJ adenocarcinoma following surgical resection in or after 2014 and who experienced recurrence at or after 6 months following postoperative adjuvant chemotherapy or who were diagnosed with unresectable advanced cancer (Stage IV) and underwent tumor sampling in or after 2014. Patients were required to have archived tissue specimens adequate to provide 14 paraffin sections.
Participant flow
NA
Adverse events
NA
Outcome measures
The primary objectives were prevalence of PD-L1 expression (combined positive score [CPS]over 1), MSI status, and EBV positivity.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 03 | Month | 27 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 19 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 21 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
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
| 2022 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039728
