UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035000 |
|---|---|
| Receipt number | R000039750 |
| Scientific Title | National Database for liver cancer and cirrhosis |
| Date of disclosure of the study information | 2018/12/01 |
| Last modified on | 2024/11/30 09:53:22 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
National Database for liver cancer and cirrhosis
Acronym
National Database for liver cancer and cirrhosis
Scientific Title
National Database for liver cancer and cirrhosis
Scientific Title:Acronym
National Database for liver cancer and cirrhosis
Region
| Japan |
Condition
Condition
Primary liver cancer or decompensated cirrhosis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To construct a national database of the patients with primary liver cancer or decompensated cirrhosis and analyze those data for future evidence
Basic objectives2
Others
Basic objectives -Others
The primary object of this study is to construct the database.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary object of this study is to construct the database.
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 primary liver cancer or decompensated cirrhosis who were admitted to hospitals which participate in the National Clinical Database
Key exclusion criteria
Patients who are hospitalized for reasons other than treatment for liver cancer or cirrhosis are excluded
Target sample size
122000
Research contact person
Name of lead principal investigator
| 1st name | Ryosuke |
| Middle name | |
| Last name | Tateishi |
Organization
The University of Tokyo Hospital
Division name
Department of Gastroenterology
Zip code
1138655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL
03-3815-5411
tateishi-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Ryosuke |
| Middle name | |
| Last name | Tateishi |
Organization
The University of Tokyo Hospital
Division name
Department of Gastroenterology
Zip code
1138655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL
03-3815-5411
Homepage URL
tateishi-tky@umin.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Health, Labor and Welfare of Japan
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
Research Ethics Committee of the Faculty of Medicine of the University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
Tel
03-5841-0818
ethics@m.u-tokyo.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
| 2018 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s00535-022-01893-5, https://www.nature.com/articles/s41598
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
| 2018 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 13 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study period: admission from January. 1st, 2018 to Mar. 31st, 2028
Management information
Registered date
| 2018 | Year | 11 | Month | 26 | Day |
Last modified on
| 2024 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039750
