UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Promoting hospital-hospital referral system for hepatitis C virus carriers to hepatologist: multi-center study
Title of the study (Brief title)	Promoting hospital-hospital referral system for hepatitis C virus carriers to hepatologist: multi-center study
Region	Japan

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

Objectives
Narrative objectives1	Our object is developing an effective regional network for hepatitis treatment, where a core center, specialized hospitals and primary physicians cooperate with each other in accordance to eradicate hepatitis C virus (HCV) in patients with HCV-related liver disease. In the present situations, only a few patients who are required HCV treatment after HCV screening test, visited hepatologists. Moreover, HCV-positive patients do not always receive appropriate hepatitis treatment at medical institutions when they visit non-specialized hospitals for liver disease. In order to address these issues, we propose a new hospital-hospital/ clinics referral system. Many HCV carriers are detected by screening tests in non-specialized hospital. However, since non-specialists aren't very familiar with liver disease, they can't necessarily provide information to their patients regarding how to be treated with viral infection or whom to consult with. Because intra-hospital referral system has been introduced in several facilities, showing effectiveness in some extent, we can apply a hospital-hospital or clinic referral system to enlarge treatment subjects and take a step forward. To establish the effective hospital network, we need the convenient referral system to disseminate the importance of hepatitis treatment for the purpose of preventing the disease progression to liver cirrhosis or hepatocellular carcinoma (HCC).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	We evaluate the effectiveness of hospital-hospital referral system for hepatitis C virus carriers to hepatologist. Our primary endpoint of this study is to increase follow-up rate and treatment rate of HCV-positive patients who are proved positive by screening test.
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. At least 18 years old 2. With chronic genotype 1 and/or genotype 2 HCV infection 3. Patients providing written informed consent
Key exclusion criteria	1. Any organ failure not due to aging 2.Decompensated cirrhotic patients 3. HCC patients 4.. Under treatment of hepatitis virus eradication 5. Severe bacterial infection 6. Severe mental illness 7. Severe cardiac disease 8. Severe endocrine metabolic disease 9. Patients with malignant tumors 10. Determined who is inappropriate by doctor
Target sample size	2000

Research contact person
Name of lead principal investigator	Yuataka Sasaki
Organization	Kumamoto University
Division name	Department of Gastroenterology and Hepatology Graduate School of Medical Sciences
Address	1-1-1 Honjo, Chuou-ku, Kumamoto City, Kumamoto 860-8556, JAPAN.
TEL	096-373-5150
Email	sasakiy@kumamoto-u.ac.jp

Public contact
Name of contact person	Hiroko Setoyama
Organization	Kumamoto University
Division name	Department of Gastroenterology and Hepatology Graduate School of Medical Sciences
Address	1-1-1 Honjo, Chuou-ku, Kumamoto City, Kumamoto 860-8556, JAPAN.
TEL	096-373-5150
Homepage URL
Email	setoyamahiroko@kuh.kumamoto-u.ac.jp

Sponsor
Institute	Kumamoto University
Institute
Department

Funding Source
Organization	Kumamoto University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

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 11 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 04 Month 26 Day
Anticipated trial start date	2017 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	We totalize the data every 3 months for the following items. (a) Total number of patients who visit our department (b) Total number of referrals from partner hospitals (c) Total number of HCV-Ab positive patients in partner hospitals (d) The number of HCV-Ab positive patients who are already under the medical treatment. (Out of (c)) (e) The number of HCV-Ab positive patients who led to treatment. (Out of (a), (c)) We also calculate follow-up rate, treatment rate, referral rate based on these data. (f) Follow-up rate = (b)/(c)-(d) (g) Treatment rate = (e)/(c)-(d) (h) Referral rate = (b)/(a)

Management information
Registered date	2017 Year 10 Month 30 Day
Last modified on	2017 Year 10 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033993