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

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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

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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name