UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031086 |
|---|---|
| Receipt number | R000035505 |
| Scientific Title | A prospective observational study to evaluate Hepatocellular Carcinoma after Achievement of Sustained Viral Response with Direct acting antivirals in chronic hepatitis C patients. |
| Date of disclosure of the study information | 2018/02/01 |
| Last modified on | 2023/08/06 14:53:39 |
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Basic information
Public title
A prospective observational study to evaluate Hepatocellular Carcinoma after Achievement of Sustained Viral Response with Direct acting antivirals in chronic hepatitis C patients.
Acronym
Hepatocellular Carcinoma after Achievement of Sustained Viral Response with Direct acting antivirals in chronic hepatitis C patients.
Scientific Title
A prospective observational study to evaluate Hepatocellular Carcinoma after Achievement of Sustained Viral Response with Direct acting antivirals in chronic hepatitis C patients.
Scientific Title:Acronym
Hepatocellular Carcinoma after Achievement of Sustained Viral Response with Direct acting antivirals in chronic hepatitis C patients.
Region
| Japan |
Condition
Condition
Chronic hepatitis C
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate frequency of hepatocellular carcinoma after achievement of sustained Viral Response with Direct acting antivirals in chronic hepatitis C patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
frequency of hepatocellular carcinoma after achievement of sustained Viral Response
Key secondary outcomes
1) Frequency of liver tumor
2) Patients' prognosis
3) The factor associated with hepatocellular carcinoma
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
1)Chronic hepatitis or cirrhosis patients with HCV
2)Without HCC when participation
3)At least 20 years old when consent is given
4)The patient has been fully informed and has an adequate understanding about the study and has given voluntary written consent before participation
Key exclusion criteria
Inappropriate patients who are judged by study-managing doctors
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Hareki |
| Middle name | |
| Last name | Uojima |
Organization
Kitasato University School of Medicine
Division name
Department of Gastroenterology
Zip code
252-0375
Address
1-15-1 Kitasato Minami Sagamihara Kanagawa 252-0374 Japan
TEL
+81-42-778-8111
kiruha@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | haruki |
| Middle name | |
| Last name | Uojima |
Organization
Kitasato University School of Medicine
Division name
Department of Gastroenterology
Zip code
252-0375
Address
1-15-1 Kitasato Minami Sagamihara Kanagawa 252-0374 Japan
TEL
+81-42-778-8111
Homepage URL
kiruha@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kitasato University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Ethics Committee of Kitasato University Hospital
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
Tel
+81-42-778-8111
mailtorinri@med.kitasato-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
| 2018 | Year | 02 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 01 | Month | 08 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 03 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
no
Management information
Registered date
| 2018 | Year | 01 | Month | 31 | Day |
Last modified on
| 2023 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035505
| 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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| Registered date | File name |
