UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046567 |
|---|---|
| Receipt number | R000053127 |
| Scientific Title | Hepatoma Registry of Integrating and Aggregating EHR (electric health record) |
| Date of disclosure of the study information | 2022/01/06 |
| Last modified on | 2024/01/11 08:59:57 |
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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, cabozantinib, durvalumab+tremelimumab, durvalumab)
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
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
y-asaoka@med.teikyo-u.ac.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
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
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
Partially published
Result
URL related to results and publications
https://ascopubs.org/doi/abs/10.1200/JCO.2023.41.4_suppl.510?af=R
Number of participants that the trial has enrolled
4307
Results
As of June 2022, 6,400 treatment lines (S 2,319, L 2559, AB 768, R 406, RAM 251, C 71) in 4,307 cases were enrolled. The response rates, disease control rates, and median treatment duration of each sequence of regimens are shown in the table. The 1st line regimen, S, L, and AB, were also used as the second and later lines in Japan and found as effective as if used as the 1st line treatment.
Results date posted
| 2024 | Year | 01 | Month | 11 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
We have decided to collect and analyze the data up to January 2024 to assess the effectiveness accurately, as the follow-up period after the second line treatment was short.
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
| 2024 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 01 | Month | 31 | Day |
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
| 2024 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053127
