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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028448
Receipt No. 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

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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
Email 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
Email htakeda@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032502

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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