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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Advanced or recurrent Hepatobiliary-pancreatic cancer with high microsatellite instability (MSI-High) | |
Classification by specialty |
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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 | |
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Interventions/Control_6 | |
Interventions/Control_7 | |
Interventions/Control_8 | |
Interventions/Control_9 | |
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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. |
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Key exclusion criteria | If it is difficult to obtain consent | |||
Target sample size | 40 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
tokusaka@ncc.go.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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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 |
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Last modified on |
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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 |