UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040366 |
|---|---|
| Receipt number | R000046055 |
| Scientific Title | A prospective observational study of screening for MSI status in unresectable advanced gastric cancer: WJOG13320GPS |
| Date of disclosure of the study information | 2020/05/11 |
| Last modified on | 2023/11/13 09:49:55 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A prospective observational study of screening for MSI status in unresectable chemo-naive advanced gastric cancer:WJOG13320GPS
Acronym
WJOG13320GPS
Scientific Title
A prospective observational study of screening for MSI status in unresectable advanced gastric cancer: WJOG13320GPS
Scientific Title:Acronym
An observational study evaluating MSI status in unresectable advanced gastric cancer
Region
| Japan |
Condition
Condition
unresectable advanced gastric cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the incidence and clinicopathological features of MSI-High advanced or recurrent chemo-naive gastric cancer
Basic objectives2
Others
Basic objectives -Others
To elucidate the incidence and clinicopathological features of MSI^High advanced or recurrent chemo-naive gastric cancer
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The proportion of patients with MSI-high in chemotherapy-naive gastric cancer
Key secondary outcomes
1) Clinicopathological features of advanced or recurrent gastric cancer with MSI-high status
2) Turn-around-time of MSI test
3) Success rate of MSI test
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)Histologically confirmed gastric or esophago-gastric junction adenocarcinoma
2)Unresectable locally advanced or metastatic adenocarcinoma of the stomach or esophago-gastric junction
3)Eastern Cooperative Oncology Group (ECOG)Performance status of 0 or 1
4)Having evaluable disease
5)No prior systemic anticancer therapy for advanced or metastatic disease. For recurrent gastric cancer patients, the last administration of prior adjuvant or neoadjuvant chemotherapy was done at least 24 weeks before enrollment.
6)Adequate organ function
7)Written informed consent
Key exclusion criteria
1)Having concomitant active malignancies.
2)Requiring systemic corticosteroid or immunosuppressant.
3)History of prior anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibody, or any other antibody which specifically targets T-cell co-stimulation or checkpoint pathways.
4)Inappropriate judged by the investigators.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Azusa |
| Middle name | |
| Last name | Komori |
Organization
Oita University Hospital
Division name
Department of Oncology
Zip code
879-5593
Address
1-1 Idaigaoka, Hasama-machi, Yufu city, Oita 879-5593 JAPAN
TEL
097(586)6275
akomori@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinichiro |
| Middle name | |
| Last name | Nakamura |
Organization
West Japan Oncology Group
Division name
WJOG datacenter
Zip code
556-0016
Address
Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka 556-0016 JAPAN
TEL
06-6633-7400
Homepage URL
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
Institute
Department
Personal name
Funding Source
Organization
Bristol-Myers Squibb Company
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Oita University
Address
1-1 Idaigaoka, Hasama-machi, Yufu city, Oita 879-5593 JAPAN
Tel
097-586-6380
rinrikenkyu@oita-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
| 2020 | Year | 05 | Month | 11 | 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
| 2020 | Year | 04 | Month | 18 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 05 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To elucidate the incidence and clinicopathological features of MSI-High advanced or recurrent chemo-naive gastric cancer
Management information
Registered date
| 2020 | Year | 05 | Month | 11 | Day |
Last modified on
| 2023 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046055
