UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062831 |
|---|---|
| Receipt number | R000069988 |
| Scientific Title | A Study of a Model for Predicting Hepatocellular Carcinoma After SVR in Patients with Non-Cirrhotic Hepatitis C in East Asia |
| Date of disclosure of the study information | 2026/09/06 |
| Last modified on | 2026/09/06 09:04:23 |
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Basic information
Public title
A Study of a Model for Predicting Hepatocellular Carcinoma After SVR in Patients with Non-Cirrhotic Hepatitis C in East Asia
Acronym
A Study of a Model for Predicting Hepatocellular Carcinoma After SVR in Patients with Non-Cirrhotic Hepatitis C in East Asia
Scientific Title
A Study of a Model for Predicting Hepatocellular Carcinoma After SVR in Patients with Non-Cirrhotic Hepatitis C in East Asia
Scientific Title:Acronym
A Study of a Model for Predicting Hepatocellular Carcinoma After SVR in Patients with Non-Cirrhotic Hepatitis C in East Asia
Region
| Japan | Asia(except Japan) |
Condition
Condition
Chronic hepatitis C
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the utility of a liver cancer prediction model in patients with hepatitis C without cirrhosis who achieved viral eradication through interferon-free therapy
Basic objectives2
Others
Basic objectives -Others
To evaluate the utility of a liver cancer prediction model in patients with hepatitis C without cirrhosis who achieved viral eradication through interferon-free therapy
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of liver cancer and risk factors for liver cancer during the observation period
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
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
Patients with hepatitis C without cirrhosis who achieved SVR with interferon-free DAA therapy
Key exclusion criteria
Cases of cirrhosis (defined as cases in which cirrhosis was clinically diagnosed based on blood tests, fibrosis markers, liver stiffness measurements, etc.)
Cases in which hepatocellular carcinoma developed prior to achieving SVR
Cases with concomitant liver disease
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Kodama |
Organization
The University of Osaka Graduated School of Medicine
Division name
Department of Gastroneterology and Hepatology
Zip code
5650871
Address
2-2, Yamadaoka, Suita, Osaka
TEL
0668793621
t-kodama@gh.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Tahata |
Organization
The University of Osaka Graduated School of Medicine
Division name
Department of Gastroneterology and Hepatology
Zip code
5650871
Address
2-2, Yamadaoka, Suita, Osaka
TEL
0668793621
Homepage URL
yuki.tahata@gh.med.osaka-u.ac.jp
Sponsor or person
Institute
The University of Osaka
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Univercity Clinical Research Review Committee
Address
2-2 Yamadaoka, Suita, Osaka
Tel
06-6210-8296
rinri@hp-crc.med.osaka-u.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 04 | Month | 04 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 19 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 23 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In the studies entitled Efficacy and Safety of Daclatasvir plus Asunaprevir Therapy for Genotype 1 Chronic Hepatitis C, Efficacy and Safety of Sofosbuvir plus Ribavirin Therapy for Genotype 2 Chronic Hepatitis C, Efficacy and Safety of Ledipasvir/Sofosbuvir Therapy for Genotype 1 Chronic Hepatitis C, Efficacy and Safety of Paritaprevir/Ombitasvir Therapy for Genotype 1 Chronic Hepatitis C, Efficacy and Safety of Elbasvir plus Grazoprevir Therapy for Genotype 1 Chronic Hepatitis C, or Efficacy and Safety of Interferon-Free Therapy for Chronic Hepatitis C, clinical information from approximately 4,000 patients has been registered at The University of Osaka and clinical information from approximately 1,000 patients has been registered at The University of Tokyo. At each institution, the information has been registered after being de-identified.
The clinical information of patients registered at The University of Tokyo will be provided to the Department of Gastroenterology and Hepatology, Graduate School of Medicine, The University of Osaka, using the coded identification numbers assigned at The University of Tokyo. No clinical information will be transferred to or received from institutions outside Japan.
Management information
Registered date
| 2026 | Year | 09 | Month | 06 | Day |
Last modified on
| 2026 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069988
