UMIN-CTR Clinical Trial

Basic information
Public title	Observational study of MSI-high Hepatobiliary and pancreatic cancer
Acronym	Study of MSI-High
Scientific Title	Observational study of MSI-high Hepatobiliary and pancreatic cancer
Scientific Title:Acronym	Study of MSI-High
Region	Japan

Condition
Condition	Advanced or recurrent Hepatobiliary-pancreatic cancer with high microsatellite instability (MSI-High)
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To clarify the characteristics of Hepatobiliary-pancreatic cancer with MSI-high and the therapeutic efficacy and prognosis of pembrolizumab.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Efficacy of pembrolizumab
Key secondary outcomes

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) MSI-High is diagnosed by MSI test kit, which is a companion diagnostic agent, or MSI-High is diagnosed by Foundation One CDx cancer genome profile. 2) Diagnosed as unresectable / recurrent hepato-biliary-pancreatic region cancer clinically / imaging 3) Cytologically or histologically diagnosed as cancer (including Group IV and class IV) 4) The person's consent has been obtained in writing.
Key exclusion criteria	If it is difficult to obtain consent
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Okusaka Middle name Last name Takuji
Organization	National Cancer Center Hospital
Division name	Department of Hepatobiliary and Pancreatic Surgery
Zip code	1040045
Address	5-1-1 Tsukiji Chuouku Tokyo
TEL	03-3542-2511
Email	tokusaka@ncc.go.jp

Public contact
Name of contact person	1st name Maruki Middle name Last name Yuta
Organization	National Canser Center
Division name	Department of Hepatobiliary and Pancreatic Oncology
Zip code	1040045
Address	5-1-1 Tsukiji Chuouku Tokyo
TEL	03-3542-2511
Homepage URL
Email	ymaruki@ncc.go.jp

Sponsor
Institute	National Canser Center
Institute
Department

Funding Source
Organization	No Funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	National Cancer Center
Address	5-1-1 Tsukiji Chuouku Tokyo
Tel	03-3542-2511
Email	NCC_IRBoffice@ml.res.ncc.go.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	2019-280
Org. issuing International ID_1	Research Ethics Review Committee
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 06 Month 01 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	Open public recruiting
Date of protocol fixation	2020 Year 03 Month 18 Day
Date of IRB	2020 Year 03 Month 18 Day
Anticipated trial start date	2020 Year 03 Month 18 Day
Last follow-up date	2022 Year 03 Month 09 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This study is being conducted as an observational study in collaboration with other institutions.

Management information
Registered date	2020 Year 05 Month 30 Day
Last modified on	2020 Year 05 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046326

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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