UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045249 |
|---|---|
| Receipt number | R000049386 |
| Scientific Title | Research study for microsatellite instability in malignancy in hepato-biliary-pancreatic field (KHBO 1903-1-2) |
| Date of disclosure of the study information | 2021/08/25 |
| Last modified on | 2021/08/24 19:17:15 |
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Basic information
Public title
Research study for microsatellite instability in malignancy in hepato-biliary-pancreatic field (KHBO 1903-1-2)
Acronym
MHBPKHBO1903-1-2
Scientific Title
Research study for microsatellite instability in malignancy in hepato-biliary-pancreatic field (KHBO 1903-1-2)
Scientific Title:Acronym
MHBPKHBO1903-1-2
Region
| Japan |
Condition
Condition
Malignancy in hepato-biliary-pancreatic field
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study is aimed to investigate the proportion of high microsatellite instability in malignancy in hepato-biliary-pancreatic field and characteristic of patients with malignancy with high microsatellite instability for the appropriate treatment selection.
Basic objectives2
Others
Basic objectives -Others
None
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The proportion of high microsatellite instability in malignancy in hepato-biliary-pancreatic field
Key secondary outcomes
characteristic of patients with malignancy with high microsatellite instability
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
| 1 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who underwent test for microsatellite instability between 2019 and 2022
Key exclusion criteria
Patients who do not agree for this study
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Shoji |
| Middle name | |
| Last name | Kubo |
Organization
Osaka City University
Division name
Department of Hepato-Biliary-Pancreatic Surgery
Zip code
545-8585
Address
1-4-3 Asahimachi, Abeno-ku, Osaka
TEL
06-6645-3841
m7696493@msic.med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | Shoji |
| Middle name | |
| Last name | Kubo |
Organization
Osaka City University
Division name
Department of Hepato-Biliary-Pancreatic Surgery
Zip code
545-8585
Address
1-4-3 Asahimachi, Abeno-ku, Osaka
TEL
06-6645-3841
Homepage URL
http://www.med.osaka-cu.ac.jp/ocum-surgery/abdomen/stuff.html
m7696493@msic.med.osaka-cu.ac.jp
Sponsor or person
Institute
Department of Hepato-Biliary-Pancreatic Surgery, Osaka City University
Institute
Department
Personal name
Funding Source
Organization
Department of Hepato-Biliary-Pancreatic Surgery, Osaka City University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Kansai Hepato-Biliary Oncology Group
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka City University
Address
1-2-7 Asahimachi, Abeno-ku, Osaka
Tel
06-6645-3456
ethics@med.osaka-cu.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
大阪国際がんセンター、京都大学、大阪大学、山口大学、兵庫医科大学、関西医科大学、国立病院機構大阪医療センター、大阪労災病院、関西電力病院、市立東大阪医療センター、ベルランド総合病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 08 | Month | 25 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 05 | Month | 19 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 29 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cohort study
Management information
Registered date
| 2021 | Year | 08 | Month | 24 | Day |
Last modified on
| 2021 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049386
