UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029755 |
|---|---|
| Receipt number | R000033993 |
| Scientific Title | Promoting hospital-hospital referral system for hepatitis C virus carriers to hepatologist: multi-center study |
| Date of disclosure of the study information | 2017/11/01 |
| Last modified on | 2017/10/30 14:05:55 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Promoting hospital-hospital referral system for hepatitis C virus carriers to hepatologist: multi-center study
Acronym
Promoting hospital-hospital referral system for hepatitis C virus carriers to hepatologist: multi-center study
Scientific Title
Promoting hospital-hospital referral system for hepatitis C virus carriers to hepatologist: multi-center study
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Yuataka Sasaki |
Organization
Kumamoto University
Division name
Department of Gastroenterology and Hepatology Graduate School of Medical Sciences
Zip code
Address
1-1-1 Honjo, Chuou-ku, Kumamoto City, Kumamoto 860-8556, JAPAN.
TEL
096-373-5150
sasakiy@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroko Setoyama |
Organization
Kumamoto University
Division name
Department of Gastroenterology and Hepatology Graduate School of Medical Sciences
Zip code
Address
1-1-1 Honjo, Chuou-ku, Kumamoto City, Kumamoto 860-8556, JAPAN.
TEL
096-373-5150
Homepage URL
setoyamahiroko@kuh.kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto University
Institute
Department
Personal name
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)
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 | 11 | 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 | 26 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033993
