UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049394 |
|---|---|
| Receipt number | R000056243 |
| Scientific Title | Liquid biopsy using microRNAs for early detection of liver fibrosis progression and hepatocellular carcinoma |
| Date of disclosure of the study information | 2022/11/01 |
| Last modified on | 2026/05/06 22:47:48 |
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Basic information
Public title
Liquid biopsy using microRNAs for early detection of liver fibrosis progression and hepatocellular carcinoma
Acronym
MicroRNAs for early detection of liver cancer
Scientific Title
Liquid biopsy using microRNAs for early detection of liver fibrosis progression and hepatocellular carcinoma
Scientific Title:Acronym
Investigation of microRNAs for early detection of liver fibrosis progression and hepatocellular carcinoma
Region
| Japan |
Condition
Condition
hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine if blood levels of microRNAs are useful as candidate biomarkers for establishing high-risk groups for hepatocellular carcinoma.
Basic objectives2
Others
Basic objectives -Others
To determine whether blood levels of microRNAs target mRNAs and gene products are useful as secondary biomarkers for establishing high-risk groups for hepatocellular carcinoma.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Blood levels of microRNAs
Key secondary outcomes
Blood levels of microRNAs target mRNAs and gene products
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with and without hepatocellular carcinoma who are being treated for liver disease
Key exclusion criteria
Those who the doctor has determined are not suitable for research
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Maiko |
| Middle name | |
| Last name | Machida |
Organization
Hokkaido University of Science
Division name
Pharmacotherapy
Zip code
006-8585
Address
15-4-1 Maeda 7-jo,Teineku,Sapporo, Japan
TEL
011-676-8652
machida-m@hus.ac.jp
Public contact
Name of contact person
| 1st name | Maiko |
| Middle name | |
| Last name | Machida |
Organization
Hokkaido University of Science
Division name
Pharmacotherapy
Zip code
006-8585
Address
15-4-1 Maeda 7-jo,Teineku,Sapporo, Japan
TEL
011-676-8652
Homepage URL
machida-m@hus.ac.jp
Sponsor or person
Institute
Hokkaido university of science, Dept.of Pharmacotherapy
Institute
Department
Personal name
Funding Source
Organization
Hokkaido university of science, Dept.of Pharmacotherapy
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committe of Hokkaido University of Science
Address
15-4-1 Maeda 7-jo,Teineku,Sapporo, Japan
Tel
011-688-2241
kenkyu@hus.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
医療法人渓仁会手稲渓仁会病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
https://drive.google.com/file/d/1KSozF29rQBg57I6PP-iDPp3yhDbCsPzj/view?usp=share_link
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
| Delay expected |
Results Delay Reason
The target number of cases has not been reached and the study period has been extended to continue accepting entries.
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
| 2021 | Year | 09 | Month | 08 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 08 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2028 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
To examine the association between blood levels of microRNAs, which may be involved in hepatocellular carcinogenesis, and patient background information. Patient background will be evaluated in relation to the presence or absence of prior viral liver disease, non-viral liver disease, prior hepatocellular carcinoma, prior treatment status, and liver function.
Management information
Registered date
| 2022 | Year | 11 | Month | 01 | Day |
Last modified on
| 2026 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056243
