UMIN-CTR Clinical Trial

Basic information
Public title	Hepatoma Registry of Integrating and Aggregating EHR (electric health record)
Acronym	HERITAGE study
Scientific Title	Hepatoma Registry of Integrating and Aggregating EHR (electric health record)
Scientific Title:Acronym	HERITAGE study
Region	Japan

Condition
Condition	Hepatocellular Carcinoma
Classification by specialty	Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To establish a registry of drug therapies for hepatocellular carcinoma.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Overall survival rate, progression-free survival rate, response rate
Key secondary outcomes	Reason for stopping treatment, cost of treatment

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	To be eligible to participate in this study, all of the following criteria must be met. 1) Patients diagnosed with hepatocellular carcinoma (HCC) by pathological diagnosis or imaging diagnosis at an NCD-registered facility after 2010 and registered in the National Liver Cancer Follow-up Database. 2) Patients who have received drug therapy for hepatocellular carcinoma at the same institution (drug therapy refers specifically to treatment with sorafenib, regorafenib, lenvatinib, ramucirumab, atezolizumab + bevacizumab, and cabozantinib)
Key exclusion criteria	Those who have requested refusal of inclusion in the research.
Target sample size	10000

Research contact person
Name of lead principal investigator	1st name Norihiro Middle name Last name Kokudo
Organization	National Center for Global Health and Medicine
Division name	President
Zip code	162-8655
Address	1-21-1 Toyama, Shinjyuku-ku, Tokyo, Japan
TEL	03-3202-7181
Email	nkokudo@hosp.ncgm.go.jp

Public contact
Name of contact person	1st name Yoshinari Middle name Last name Asaoka
Organization	Teikyo University School of Medicine
Division name	Department of Medicine
Zip code	173-8605
Address	2-11-1 Kaga Itabashi-ku, Tokyo, Japan
TEL	03-3964-1211
Homepage URL
Email	y-asaoka@med.teikyo-u.ac.jp

Sponsor
Institute	National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization	Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	National Center for Global Health and Medicine
Address	1-21-1 Toyama, Shinjyuku-ku, Tokyo, Japan
Tel	03-3202-7181
Email	kenkyu-shinsa@hosp.ncgm.go.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

Other administrative information
Date of disclosure of the study information	2022 Year 01 Month 06 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 08 Month 12 Day
Date of IRB	2020 Year 10 Month 12 Day
Anticipated trial start date	2021 Year 01 Month 14 Day
Last follow-up date	2022 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

We will conduct a retrospective, cohort, multicenter study using medical records to investigate the status of drug therapies for hepatocellular carcinoma (HCC). Patients who received drug therapy for HCC after April 2015 will be extracted from the medical records of each member of NCD-registered facilities, and information of treatment, including the efficacy, treatment duration, reasons for treatment discontinuation, and second- and third-line treatments will be collected.

Management information
Registered date	2022 Year 01 Month 06 Day
Last modified on	2022 Year 01 Month 06 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053127

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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