UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040366
Receipt No. 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 2020/05/11

* 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 given as primary 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
Email 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
Email datacenter@wjog.jp

Sponsor
Institute West Japan Oncology Group
Institute
Department

Funding Source
Organization West Japan Oncology Group
Organization
Division
Category of Funding Organization Self funding
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
Email 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 Preinitiation
Date of protocol fixation
2020 Year 04 Month 18 Day
Date of IRB
Anticipated trial start date
2020 Year 11 Month 01 Day
Last follow-up date
2024 Year 10 Month 31 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
2020 Year 05 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046055

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.