Liver DiseasesNCT04525833
Liver Disease and Other Systemic Diseases
An observational study of Liver Diseases and Humans, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation at 1 site in Taiwan.
Trial summary
Examine the association of chronic liver diseases (including hepatitis B, hepatitis C, alcoholic liver disease, fatty liver, liver cirrhosis, and hepatocellular carcinoma) with other systemic diseases by retrospectively analyzing the data from the Hospital Database of Buddhist Tzu Chi Medical Foundation. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Diseases, Humans, Progression
- How many people
- 15,000 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2020to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Data collected from the Hospital Database of Buddhist Tzu Chi Medical Foundation
Who may be able to join
- Individuals who visited the gastroenterology clinics of the Tzu Chi Hospitals, Buddhist Tzu Chi Medical Foundation
Who cannot join
- Age younger than 18 or older than 99 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Ching-Sheng Hsu
New Taipei City, 23142
Ching-Sheng Hsu, Ph.D, 886979239381, hsu.chingsheng@gmail.com
Chih-Wei Tseng, Ph.D, 886979239381, cwtseng2@gmail.com
About this study
Official title: The Association of Liver Disease With Other Systemic Diseases, Focus on Diseases Progression, Treatments, and Clinical Outcomes: Analyses From the Hospital Database of Buddhist Tzu Chi Medical Foundation
Examine the association of chronic liver diseases (including hepatitis B, hepatitis C, alcoholic liver disease, fatty liver, liver cirrhosis, and hepatocellular carcinoma) with other systemic diseases by retrospectively analyzing the data from the Hospital Database of Buddhist Tzu Chi Medical Foundation.
Read the detailed description
The global population is growing older over the next several decades. An essential component to keep people healthy, even with aging, is to prevent chronic disease progression and reduce associated complications. About 80% of older adults have one chronic condition, and 50% have at least two chronic disorders. Efforts to identify strategies to prevent or reduce the risk of chronic diseases and injuries and to widely apply effective interventions must be pursued. Because the liver is the largest solid organ in the human body with multiple functions, including nutrition, metabolism, proteins and biochemicals synthesis, and detoxification, its function is vital for the homeostasis of our body. The impairment of liver function may cause dysfunction or even shut down other systems in our body. Therefore, a better understanding of the pathogenesis of the liver disorder is not only a key issue in medical science, but it may also affect the general health and diseases of other body systems in a variety of ways. Finally, causing significant public health and economic losses globally. However, the impact and interactions of liver disorders on the progression, treatments, and prognosis of other systemic disorders, or vice versa, remain largely unknown. Recent studies have demonstrated the interactions between diabetes mellitus and liver diseases, and implying a possible deteriorating effect of diabetes on liver disease progression, treatment outcomes, and hepatic carcinogenesis. These lines of evidence not only verify the need for a better understanding of the interactions between liver and other disorders, but also justify a more extensive exploration of the interactions between liver diseases and other systemic disorders.
In this study, the investigators aim to examine the association of chronic liver diseases (including hepatitis B, hepatitis C, alcoholic liver disease, fatty liver, liver cirrhosis and hepatocellular carcinoma) with other systemic diseases by retrospectively analyzing the data from the Hospital Database of Buddhist Tzu Chi Medical Foundation. The investigators will examine the impacts of different systemic diseases on the disease progression and prognosis of Taiwanese patients with liver diseases and vice versa. Moreover, the investigators will also examine the different therapeutic strategies (including western, traditional Chinese medical, surgical or varied treatments) used for the treatments of liver diseases or systemic diseases, and their effects on the disease progression, long-term outcomes and prognosis of patients with chronic liver diseases or other systemic diseases in Taiwan.
- Conditions
- Liver Diseases, Humans, Progression, Carcinogenesis, Fatty Liver Disease, Hepatitis C
- Medical subject headings
- Liver Diseases, Disease Progression, Carcinogenesis, Non-alcoholic Fatty Liver Disease, Hepatitis C, Hepatitis B, Carcinoma, Hepatocellular
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of a new diagnosis of hepatocellular carcinoma (HCC)
The new diagnosis of HCC is assessed every 3 months by abdominal sonography, and every 6 months with tumor markers (e.g. AFP), and confirmed by dynamic CT or MRI or pathological examination.
Measured: From the date of enrollment until the date of first documented diagnosis of HCC, assessed up to 120 months.
The incidence of a new diagnosis of any event of liver cirrhosis complications
Liver cirrhosis complications include ascites, esophageal or gastric varices bleeding, hepatorenal syndrome, spontaneous bacterial peritonitis, hepatic encephalopathy, hepatic pulmonary syndrome, liver failure (Child-Pugh score B or C), or liver transplant, that are assessed every 3 months clinically.
A new diagnosis of any event of liver cirrhosis complications is a new documented any of the above liver cirrhosis complications, whichever came first.
Measured: From the date of enrollment until the date of first documented any event of liver cirrhosis complications, or date of death from any cause, whichever came first, assessed up to 120 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2020
- Study start1 Jan 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 15,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Dalin Tzu Chi General Hospital
- Responsible party
- Sponsor
- Investigators
- Ching-Sheng Hsu, Ph.D, Principal investigator, Liver Diseases Research Center, Taipei Tzu Chi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04525833
- Sponsor's protocol ID
- B10804008
- Status last verified
- Sep 2025
- First submitted
- 4 Aug 2020
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Publications
Wu CC, Tseng CW, Tseng KC, Chen YC, Wu TW, Chang SY, Chang YJ, Chao YC, Hsu CS. Radiofrequency ablation versus surgical resection for the treatment of solitary hepatocellular carcinoma 2 cm or smaller: A cohort study in Taiwan. J Formos Med Assoc. 2021 May;120(5):1249-1258. doi: 10.1016/j.jfma.2020.11.010. Epub 2020 Dec 4.
PubMed 33288401
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association of Liver Disease With Other Systemic Diseases, Focus on Diseases Progression, Treatments, and Clinical Outcomes: Analyses From the Hospital Database of Buddhist Tzu Chi Medical Foundation
- ClinicalTrials.gov ID
- NCT04525833
- Acronym / sponsor ID
- B10804008
- Conditions
- Liver Diseases, Humans, Progression, Carcinogenesis, Fatty Liver Disease, Hepatitis C
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical FoundationUniversity, hospital or other
- Collaborators
- Dalin Tzu Chi General Hospital
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Examine the association of chronic liver diseases (including hepatitis B, hepatitis C, alcoholic liver disease, fatty liver, liver cirrhosis, and hepatocellular carcinoma) with other systemic diseases by retrospectively analyzing the data from the Hospital Database of Buddhist Tzu Chi Medical Foundation.
Detailed description
The global population is growing older over the next several decades. An essential component to keep people healthy, even with aging, is to prevent chronic disease progression and reduce associated complications. About 80% of older adults have one chronic condition, and 50% have at least two chronic disorders. Efforts to identify strategies to prevent or reduce the risk of chronic diseases and injuries and to widely apply effective interventions must be pursued. Because the liver is the largest solid organ in the human body with multiple functions, including nutrition, metabolism, proteins and biochemicals synthesis, and detoxification, its function is vital for the homeostasis of our body. The impairment of liver function may cause dysfunction or even shut down other systems in our body. Therefore, a better understanding of the pathogenesis of the liver disorder is not only a key issue in medical science, but it may also affect the general health and diseases of other body systems in a variety of ways. Finally, causing significant public health and economic losses globally. However, the impact and interactions of liver disorders on the progression, treatments, and prognosis of other systemic disorders, or vice versa, remain largely unknown. Recent studies have demonstrated the interactions between diabetes mellitus and liver diseases, and implying a possible deteriorating effect of diabetes on liver disease progression, treatment outcomes, and hepatic carcinogenesis. These lines of evidence not only verify the need for a better understanding of the interactions between liver and other disorders, but also justify a more extensive exploration of the interactions between liver diseases and other systemic disorders.
In this study, the investigators aim to examine the association of chronic liver diseases (including hepatitis B, hepatitis C, alcoholic liver disease, fatty liver, liver cirrhosis and hepatocellular carcinoma) with other systemic diseases by retrospectively analyzing the data from the Hospital Database of Buddhist Tzu Chi Medical Foundation. The investigators will examine the impacts of different systemic diseases on the disease progression and prognosis of Taiwanese patients with liver diseases and vice versa. Moreover, the investigators will also examine the different therapeutic strategies (including western, traditional Chinese medical, surgical or varied treatments) used for the treatments of liver diseases or systemic diseases, and their effects on the disease progression, long-term outcomes and prognosis of patients with chronic liver diseases or other systemic diseases in Taiwan.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Data collected from the Hospital Database of Buddhist Tzu Chi Medical Foundation
Key inclusion criteria (1 listed)
- Individuals who visited the gastroenterology clinics of the Tzu Chi Hospitals, Buddhist Tzu Chi Medical Foundation
Key exclusion criteria (1 listed)
- Age younger than 18 or older than 99 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The incidence of a new diagnosis of hepatocellular carcinoma (HCC)
Time frame: From the date of enrollment until the date of first documented diagnosis of HCC, assessed up to 120 months.
The new diagnosis of HCC is assessed every 3 months by abdominal sonography, and every 6 months with tumor markers (e.g. AFP), and confirmed by dynamic CT or MRI or pathological examination.
The incidence of a new diagnosis of any event of liver cirrhosis complications
Time frame: From the date of enrollment until the date of first documented any event of liver cirrhosis complications, or date of death from any cause, whichever came first, assessed up to 120 months.
Liver cirrhosis complications include ascites, esophageal or gastric varices bleeding, hepatorenal syndrome, spontaneous bacterial peritonitis, hepatic encephalopathy, hepatic pulmonary syndrome, liver failure (Child-Pugh score B or C), or liver transplant, that are assessed every 3 months clinically. A new diagnosis of any event of liver cirrhosis complications is a new documented any of the above liver cirrhosis complications, whichever came first.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Derived from this study: PubMed 33288401Wu CC, Tseng CW, Tseng KC, Chen YC, Wu TW, Chang SY, Chang YJ, Chao YC, Hsu CS. Radiofrequency ablation versus surgical resection for the treatment of solitary hepatocellular carcinoma 2 cm or smaller: A cohort study in Taiwan. J Formos Med Assoc. 2021 May;120(5):1249-1258. doi: 10.1016/j.jfma.2020.11.010. Epub 2020 Dec 4.
- Individual participant dataSharing planned: Undecided. Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ching-Sheng Hsu, Ph.D principal investigator
Liver Diseases Research Center, Taipei Tzu Chi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Diseases and Humans, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ching-Sheng Hsu, Ph.D (886-979239381, hsu.chingsheng@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of a new diagnosis of hepatocellular carcinoma (HCC) (time frame: From the date of enrollment until the date of first documented diagnosis of HCC, assessed up to 120 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04525833, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.