UMIN-CTR Clinical Trial

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
Email	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
Email	m7696493@msic.med.osaka-cu.ac.jp

Sponsor
Institute	Department of Hepato-Biliary-Pancreatic Surgery, Osaka City University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049386