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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040591
Receipt No. R000046326
Scientific Title Observational study of MSI-high Hepatobiliary and pancreatic cancer
Date of disclosure of the study information 2020/06/01
Last modified on 2020/05/30

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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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