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RecruitingNCT04525833Updated Sep 19, 2025

Liver Disease and Other Systemic Diseases

An observational study in Liver Diseases, Humans and Progression, sponsored by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation. Recruiting at 1 site in Taiwan. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-19.

Sponsored by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started Jan 2020; still recruiting 6 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
15,000
Ages
18 Years to 99 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Liver Diseases
  • Humans
  • Progression
  • Carcinogenesis
  • Fatty Liver Disease
  • Hepatitis C
  • Hepatitis B
  • Hepatocellular Carcinoma
  • Liver Cirrhoses
  • Treatment Outcome
03

In context

Liver Diseases

824 studies on the registry are indexed under Liver Diseases; 152 are open to participants now.

This study's planned enrollment of 15,000 is above the median of 200 across 262 observational studies indexed under Liver Diseases.

Browse Liver Diseases studies →

Lead sponsor

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation is the lead sponsor of 58 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Age younger than 18 or older than 99 years
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
15,000 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From the date of enrollment until the date of first documented diagnosis of HCC, assessed up to 120 months.

  2. 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.

    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.

07

Study locations

1 of 1 sites recruiting
  • Ching-Sheng Hsu
    New Taipei City, 23142, Taiwan
    Recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: Undecided — Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2020 (actual). Primary completion is estimated for Dec 2025, 71 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 4, 2020
First posted
Aug 25, 2020
StartActual
Jan 1, 2020
Primary completionEst.
Dec 31, 2025
CompletionEst.
Dec 31, 2026
Last update
Sep 19, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04525833
Lead sponsor
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Collaborators
Dalin Tzu Chi General Hospital
Responsible party
Sponsor
First posted
Aug 25, 2020
Start date
Jan 1, 2020
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Sep 19, 2025

Study contacts

Ching-Sheng Hsu, Ph.D
Contact
hsu.chingsheng@gmail.com
886-979239381
Ching-Sheng Hsu
Contact
hsu.chingsheng@gmail.com
886-979239381
Ching-Sheng Hsu, Ph.D
principal investigator · Liver Diseases Research Center, Taipei Tzu Chi Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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