UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029040 |
|---|---|
| Receipt number | R000033217 |
| Scientific Title | The role of exogenous genes in the pathogenesis of human cholestatic liver diseases. |
| Date of disclosure of the study information | 2017/09/07 |
| Last modified on | 2024/03/13 10:51:07 |
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Basic information
Public title
The role of exogenous genes in the pathogenesis of human cholestatic liver diseases.
Acronym
Exogenous genes and human cholestatic liver diseases.
Scientific Title
The role of exogenous genes in the pathogenesis of human cholestatic liver diseases.
Scientific Title:Acronym
Exogenous genes and human cholestatic liver diseases.
Region
| Japan |
Condition
Condition
Primary biliary cholangitis, Primary sclerosing cholangitis, autoimmune hepatitis, autoimmune liver diseases, cholestatic liver diseases
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Detection of exogenous genes from serum or
liver tissue samples obtained from patients with cholestatic liver diseases (primary biliary cholangitis, primary sclerosing cholangitits, etc), and evaluate their roles in the pathogenesis.
Basic objectives2
Others
Basic objectives -Others
Finding novel biomarkers for cholestatic liver diseases.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Detection of exogenous genes from serum or liver tissue samples, and evaluate their specificity.
Key secondary outcomes
Evaluation of their role in the pathogenesis.
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
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients diagnosis with cholestatic liver diseases (PBC, PSC, AIH, etc) by serum with/without pathological examinations.
Key exclusion criteria
Liver diseases caused by other factors such as hepatitis virus.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Ueno |
Organization
Yamagata University Faculty of Medicine
Division name
Gastroenterology
Zip code
990-9585
Address
2-2-2, Iidanishi, Deparment of Gastroenterology
TEL
0239285309
y-ueno@med.id.yamagata-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Ueno |
Organization
Yamagata University Faculty of Medicine
Division name
Gastroenterology
Zip code
990-9585
Address
2-2-2 Iidanishi, Yamagata, 9909585, Japan
TEL
023-628-5309
Homepage URL
y-ueno@med.id.yamagata-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, Yamagata University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yamagata University
Address
2-2-2 Iidanishi Yamagata 9909585 JAPAN
Tel
023-628-5048
ikekenkyu@jm.kj.yamagata-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
山形大学医学部附属病院（山形県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | Month | 07 | 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
| Delay expected |
Results Delay Reason
Delay for the data analysis.
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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 08 | Month | 28 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 28 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
This is an observational study using serum, bile, saliva, or liver biopsy specimens.
Management information
Registered date
| 2017 | Year | 09 | Month | 07 | Day |
Last modified on
| 2024 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033217
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
