UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053108 |
|---|---|
| Receipt number | R000060498 |
| Scientific Title | Non-interventional Prospective Observational Study: Exploration of Long-Term Prognostic Indicators in Patients with Chronic Liver Disease |
| Date of disclosure of the study information | 2023/12/19 |
| Last modified on | 2024/07/16 14:58:18 |
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Basic information
Public title
Non-interventional Prospective Observational Study: Exploration of Long-Term Prognostic Indicators in Patients with Chronic Liver Disease
Acronym
Non-interventional Prospective Observational Study: Exploration of Long-Term Prognostic Indicators in Patients with Chronic Liver Disease
Scientific Title
Non-interventional Prospective Observational Study: Exploration of Long-Term Prognostic Indicators in Patients with Chronic Liver Disease
Scientific Title:Acronym
Non-interventional Prospective Observational Study: Exploration of Long-Term Prognostic Indicators in Patients with Chronic Liver Disease
Region
| Japan |
Condition
Condition
Patients diagnosed with chronic liver diseases (such as viral chronic hepatitis, non-alcoholic fatty liver disease, alcoholic liver disease, primary biliary cholangitis, autoimmune hepatitis, metabolic liver diseases, congestive hepatopathy, liver tumors, etc.) who meet all the selection criteria below and do not meet any of the exclusion criteria shall be considered eligible for registration.
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to explore clinical indicators and biomarkers useful for predicting the long-term prognosis of patients with chronic liver diseases.
Basic objectives2
Others
Basic objectives -Others
Identification of poor prognostic cases among chronic liver disease patients and early therapeutic intervention.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We will assess the prognosis optimistically. Prognosis encompasses overall survival duration, occurrence of hepatic events, cardiovascular events, development of multi-organ cancers, and onset of renal failure.
Key secondary outcomes
Clinical laboratory values (WBC, RBC, Hb, Plt, PT%, TP, Alb, BUN, Cre, eGFR, Na, K, Cl, T-Bil, D-Bil, I-Bil, AST, ALT, AFP, AFP-L3, PIVKA-II, 4th generation C7S, M2BPGi, Autotaxin, anti-mitochondrial antibodies, anti-M2 mitochondrial antibodies, anti-centromere antibodies, anti-nuclear antibodies, anti-nuclear membrane antibodies, urine qualitative test, urine sediment, etc.), body composition (Inbody), liver histopathology findings, imaging findings (CT, MRI, US, Fibroscan).
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with chronic liver diseases at our department
(including cases diagnosed with chronic liver diseases simultaneously with liver cancer)
Key exclusion criteria
Cases where consent via written documentation for research participation cannot be obtained.
Cases below 20 years old and those above 90 years old will be excluded.
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Takanobu |
| Middle name | |
| Last name | Iwadare |
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
TEL
0263372634
22hm104g@shinshu-u-ac.jp
Public contact
Name of contact person
| 1st name | Takanobu |
| Middle name | |
| Last name | Iwadare |
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
TEL
0263372634
Homepage URL
22hm104g@shinshu-u-ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
none
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
Shinshu University School of Medicine
Address
3-1-1 Asahi, Matsumoto, Nagano
Tel
0263372634
shinhp@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
| 2023 | Year | 12 | Month | 19 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 11 | Month | 09 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 09 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 09 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Research Outline
Patients diagnosed with chronic liver diseases at our department will be registered. Pertinent details of these patients, such as demographic information, performance status (PS), age, gender, height, weight, medical history, comorbidities, present illness, social history (smoking history, alcohol consumption, family background, history of blood transfusions, etc.), medication use, etiology of liver diseases (such as hepatitis B, hepatitis C, alcoholic liver disease, non-alcoholic fatty liver disease, autoimmune hepatitis, etc.), clinical laboratory values (WBC, RBC, Hb, Plt, PT%, TP, Alb, BUN, Cre, eGFR, Na, K, Cl, T-Bil, D-Bil, I-Bil, AST, ALT, AFP, AFP-L3, PIVKA-II, 4th generation C7S, M2BPGi, Autotaxin, anti-mitochondrial antibodies, anti-M2 mitochondrial antibodies, anti-centromere antibodies, anti-nuclear antibodies, anti-nuclear membrane antibodies, urine qualitative test, urine sediment, etc.), presence of ascites, presence of hepatic encephalopathy, presence of varices, liver histopathology findings, imaging findings (CT, MRI, US, Fibroscan), and body composition (InBody), will be registered for the purpose of examining their prognosis optimistically. Prognosis will encompass not only survival but also occurrences of hepatic events (such as liver cancer, encephalopathy, ascites, jaundice), cardiovascular events, multi-organ cancers, and the presence of renal failure.
Management information
Registered date
| 2023 | Year | 12 | Month | 14 | Day |
Last modified on
| 2024 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060498
