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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027801
Receipt No. R000031854
Scientific Title The prognosis of older patients treated about the chronic hepatitis C in the North area of Kyoto, Japan
Date of disclosure of the study information 2017/07/01
Last modified on 2017/06/18

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Basic information
Public title The prognosis of older patients treated about the chronic hepatitis C in the North area of Kyoto, Japan
Acronym The prognosis of older HCV patients in the North area of Kyoto, Japan
Scientific Title The prognosis of older patients treated about the chronic hepatitis C in the North area of Kyoto, Japan
Scientific Title:Acronym The prognosis of older HCV patients in the North area of Kyoto, Japan
Region
Japan

Condition
Condition Chronic Hepatitis C
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to be clear the carcinogenesis of HCC, the background, the change of liver function, the direct cause of death of the older patients after treated the chronic hepatitis C.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cumulative carcinogenic rate
Key secondary outcomes SVR rate, the Over all survival, Recurrence rate, the transition of liver function, liver fibrosis, The event related liver disease and cardiovascular disease.

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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The objects are 65 years or higher patients treated the chronic hepatitis C in our hospital.
Key exclusion criteria none
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Ishiba
Organization The North Center of Kyoto prefectural university of medicine
Division name Gastroenterology and Hepatology
Zip code
Address 481 Otokoyama Yosanocho Yosagun, Kyoto, Japan
TEL 0772-46-3371
Email chiroinu@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Ishiba
Organization The North Center of Kyoto prefectural university of medicine
Division name Gastroenterology and Hepatology
Zip code
Address 481 Otokoyama Yosanocho Yosagun, Kyoto, Japan
TEL 0772-46-3371
Homepage URL
Email chiroinu@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto prefectural university of medicine
Institute
Department

Funding Source
Organization none
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
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 07 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 04 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 08 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 The objects are the 65 years or higher patients who treated the chronic hepatitis C from April 2014. The observation period is 12 years until March 2026.

Management information
Registered date
2017 Year 06 Month 18 Day
Last modified on
2017 Year 06 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031854

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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