NCT04525833

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15,000

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Jan 2020Dec 2026

Study Start

First participant enrolled

January 1, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2020

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 25, 2020

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

6 years

First QC Date

August 4, 2020

Last Update Submit

September 16, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    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.

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Age younger than 18 or older than 99 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ching-Sheng Hsu

New Taipei City, 23142, Taiwan

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Liver DiseasesDisease ProgressionCarcinogenesisNon-alcoholic Fatty Liver DiseaseHepatitis CHepatitis BCarcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Digestive System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplastic ProcessesNeoplasmsFatty LiverBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisHepadnaviridae InfectionsDNA Virus InfectionsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeLiver NeoplasmsDigestive System NeoplasmsNeoplasms by Site

Study Officials

  • Ching-Sheng Hsu, Ph.D

    Liver Diseases Research Center, Taipei Tzu Chi Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ching-Sheng Hsu, Ph.D

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2020

First Posted

August 25, 2020

Study Start

January 1, 2020

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

September 19, 2025

Record last verified: 2025-09

Locations