Liver Disease and Other Systemic Diseases

Hepatocellular Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04525833
• Other study ID #: B10804008
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: August 2020
• Source: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
• Contact: Ching-Sheng Hsu, Ph.D
• Phone: 886-979239381
• Email: hsu.chingsheng[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15000
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Taiwan	Ching-Sheng Hsu	New Taipei City

Sponsors (2)

Lead Sponsor	Collaborator
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation	Dalin Tzu Chi General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.