UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050649 |
|---|---|
| Receipt number | R000057707 |
| Scientific Title | Survey on Current Status and Treatment of Hepatitis and Liver Cancer in the Asia-Pacific Region |
| Date of disclosure of the study information | 2023/03/23 |
| Last modified on | 2023/03/22 18:09:18 |
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Basic information
Public title
Survey on Current Status and Treatment of Hepatitis and Liver Cancer in the Asia-Pacific Region
Acronym
A-HOC(APASL Hepatology/Oncology Consortium)
Scientific Title
Survey on Current Status and Treatment of Hepatitis and Liver Cancer in the Asia-Pacific Region
Scientific Title:Acronym
A-HOC(APASL Hepatology/Oncology Consortium)
Region
| Japan | Asia(except Japan) |
Condition
Condition
Patients diagnosed with HCC at the collaborating institution beginning January 1, 2013, including newly diagnosed patients during the study enrollment period.
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The Asia-Pacific region is known for its high incidence of hepatitis and liver cancer (HCC) worldwide. This study will examine the actual incidence and treatment of HCC in the countries of the region, as well as the background of viral and non-viral hepatitis, and examine in depth the health and medical issues in each country.
Basic objectives2
Others
Basic objectives -Others
To understand the actual treatment status of HCC in Asia-Pacific countries and to deeply examine the actual status of the development of new treatment methods.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall survival from the time of diagnosis of HCC.
Key secondary outcomes
Diagnostic methods used as the basis for the diagnosis of HCC
Evaluation of liver function at the time of detection and the degree of progression of HCC
Causes of background liver damage
Sequence and combination of treatments
Status and efficacy of new drugs
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
| 1 | years-old | <= |
Age-upper limit
| 120 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with HCC at the collaborating institution beginning January 1, 2013, including newly diagnosed patients during the study enrollment period.
Key exclusion criteria
None
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Mochizuki |
Organization
Yamanashi Prefectural Central Hospital
Division name
Genome Analysis Center / Department of Gastroenterology
Zip code
4008506
Address
1-1-1 Fujimi-cho, Kofu-city, Yamanashi-prefecture,Japan
TEL
+81-553-7111
mochiduki-ypch@umin.ac.jp
Public contact
Name of contact person
| 1st name | Izumi |
| Middle name | |
| Last name | Nakano |
Organization
Asian Pacific Association for the Study of the Liver (APASL)
Division name
Secretariat
Zip code
160-0022
Address
1-24-7-920 Shinjyuku,Shinjyuku-ku, Tokyo, Japan
TEL
03-5312-7686
Homepage URL
apasl_secretariat@apasl.info
Sponsor or person
Institute
Yamanashi Prefectural Centeral Hospital
Institute
Department
Personal name
Funding Source
Organization
Asian Pacific Association for the Study of the Liver (APASL)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yamanashi Prefectural Central Hospital Clinical Research Committee
Address
1-1-1 Fujimi,Kofu-city,Yamanashi-prefecture,Japan
Tel
+81-553-7111
clinical-research@ych.pref.yamanashi.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
| 2023 | Year | 03 | Month | 23 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 03 | Month | 14 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2027 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2028 | Year | 12 | Month | 31 | Day |
Other
Other related information
Observational studies tracking the background, epidemiology, diagnosis, treatment, and prognosis of HCC
Management information
Registered date
| 2023 | Year | 03 | Month | 22 | Day |
Last modified on
| 2023 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057707
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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