UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028448 |
|---|---|
| Receipt number | R000032502 |
| Scientific Title | A prospective study to investigate clinical factors predicting hepatocarcinogenesis after the eradication of hepatitis C virus. |
| Date of disclosure of the study information | 2017/12/01 |
| Last modified on | 2017/07/31 09:50:27 |
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Basic information
Public title
A prospective study to investigate clinical factors predicting hepatocarcinogenesis after the eradication of hepatitis C virus.
Acronym
A study to investigate clinical factors predicting hepatocarcinogenesis after HCV eradication.
Scientific Title
A prospective study to investigate clinical factors predicting hepatocarcinogenesis after the eradication of hepatitis C virus.
Scientific Title:Acronym
A study to investigate clinical factors predicting hepatocarcinogenesis after HCV eradication.
Region
| Japan |
Condition
Condition
hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To explore factors predicting hepatocarcinogenesis after eradication of hepatitis C virus.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical factors associated with hepatocarcinogenesis after HCV eradication.
Key secondary outcomes
Cancer-free survival time after HCV eradication
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 chronic hepatitis or liver cirrhosis who have received interferon-free anti-HCV therapy with oral antivirals for serotype 1 or 2 HCV infection.
Key exclusion criteria
1. Patients without any evaluation of the efficacy of anti-HCV therapy.
2. Patients whose clinical course after anti-HCV therapy cannot be tracked.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Marusawa |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
54, Shogoin-Kawahara-cho, Sakyo-ku, Kyoto, Japan
TEL
075-751-4319
maru@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Haruhiko Takeda |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
54, Shogoin-Kawahara-cho, Sakyo-ku, Kyoto, Japan
TEL
075-751-4319
Homepage URL
htakeda@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
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
Address
Tel
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
| 2017 | Year | 12 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 08 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Blood examination and abdominal ultrasound sonography or CT scan every 3 or 6 months are scheduled after anti-HCV therapy according to daily clinical practice.
Management information
Registered date
| 2017 | Year | 07 | Month | 31 | Day |
Last modified on
| 2017 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032502
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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