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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044114
Receipt No. R000049365
Scientific Title Prospective observational study aiming micro-elimination of hepatitis C virus in Nagawa town
Date of disclosure of the study information 2021/05/15
Last modified on 2021/05/06

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Basic information
Public title Prospective observational study aiming micro-elimination of hepatitis C virus in Nagawa town
Acronym Prospective observational study aiming micro-elimination of hepatitis C virus in Nagawa town
Scientific Title Prospective observational study aiming micro-elimination of hepatitis C virus in Nagawa town
Scientific Title:Acronym Prospective observational study aiming micro-elimination of hepatitis C virus in Nagawa town
Region
Japan

Condition
Condition Viral hepatitis
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In order to eradicate viral hepatitis, hepatitis virus testing should be conducted in all cases in the regional cohort first, and some motivation should be given to those who are positive for the test to increase the rate of secondary scrutiny.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Measure hepatitis virus markers to reveal viral hepatitis positive cases
Key secondary outcomes

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 Nagawa Town Citizens' Dock and Specific Medical Examination (biennial) examinees and members of the Japan Health Insurance Association, etc.
Key exclusion criteria Residents who did not consent to this research test. Patients who have already been diagnosed with viral hepatitis and have started treatment. Patients who cannot receive medical examinations because they require nursing care 3 or more
Target sample size 3900

Research contact person
Name of lead principal investigator
1st name Satoru
Middle name
Last name Joshita
Organization Shinshu University School of Medicine
Division name Department of Medicine, Division of Gastroenterology and Hepatology
Zip code 390-8621
Address 3-1-1 Asahi, Matsumoto, Nagano , Japan
TEL 0263372634
Email ninai@shinshu-u.ac.jp

Public contact
Name of contact person
1st name Satoru
Middle name
Last name Joshita
Organization Shinshu University School of Medicine
Division name Department of Medicine, Division of Gastroenterology and Hepatology
Zip code 390-8621
Address 3-1-1 Asahi, Matsumoto, Nagano , Japan
TEL 0263372634
Homepage URL
Email ninai@shinshu-u.ac.jp

Sponsor
Institute Shinshu University
Institute
Department

Funding Source
Organization Sysmex Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Yodakubo Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization Shinshu University School of Medicine
Address 3-1-1 Asahi, Matsumoto, Nagano , Japan
Tel 0263372634
Email ninai@shinshu-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
2021 Year 05 Month 15 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
2020 Year 12 Month 23 Day
Date of IRB
Anticipated trial start date
2021 Year 06 Month 01 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information observational study

Management information
Registered date
2021 Year 05 Month 06 Day
Last modified on
2021 Year 05 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049365

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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