Liver Disease and Other Systemic Diseases

September 16, 2025 updated by: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Data collected from the Hospital Database of Buddhist Tzu Chi Medical Foundation

Description

Inclusion Criteria:

  • Individuals who visited the gastroenterology clinics of the Tzu Chi Hospitals, Buddhist Tzu Chi Medical Foundation

Exclusion Criteria:

  • Age younger than 18 or older than 99 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Dalin Tzu Chi General Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ching-Sheng Hsu, Ph.D, Liver Diseases Research Center, Taipei Tzu Chi Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 4, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 25, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 19, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B10804008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Liver Diseases

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings