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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06325267
Other study ID # PLC
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2010
Est. completion date August 31, 2024

Study information

Verified date March 2024
Source The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Contact Jie Li, M.D.,Ph.D
Phone 15863787910
Email lijier@nju.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Primary liver cancer (PLC) is the sixth most common malignancy in the world and the third most common cause of malignancy death. In 2020, there were about 905,677 new cases of PLC worldwide, and 830,180 deaths. Despite the availability of a variety of treatments for PLC, the 5-year net survival rate is still only 5% to 30%. How to effectively reduce the disease burden of PLC is a major public health problem that needs to be solved worldwide. The clinical characteristics and prognosis of PLC caused by different pathogenic factors are different. Therefore, it is of great significance to fully identify the risk factors of PLC, be familiar with the clinical characteristics and prognosis of disease development, and understand the relevant monitoring and follow-up strategies for the prevention and treatment of PLC.


Description:

Primary liver cancer (PLC) is the sixth most common malignancy in the world and the third most common cause of malignancy death. PLC mainly includes hepatocellular carcinoma (75%-85%) and intrahepatic cholangiocarcinoma (10%-15%). In 2020, there were about 905,677 new cases of PLC worldwide, and 830,180 deaths. Despite the availability of a variety of treatments for PLC, the 5-year net survival rate is still only 5% to 30%. How to effectively reduce the disease burden of PLC is a major public health problem that needs to be solved worldwide. Common risk factors for PLC include Hepatitis B virus (HBV), Hepatitis C virus (HCV) infection, alcohol consumption, metabolic factors, etc. Although antiviral drugs can control or even cure chronic HBV and HCV to a certain extent, chronic viral infection is still the leading cause of PLC worldwide. In addition, with the prevalence of obesity, diabetes and non-alcoholic fatty liver disease (NAFLD), the incidence of non-infectious PLC is gradually increasing. In recent years, NAFLD has gradually become the leading cause of liver transplant waiting list for patients with hepatocellular carcinoma in the United States. The clinical characteristics and prognosis of PLC caused by different pathogenic factors are different. Therefore, it is of great significance to fully identify the risk factors of PLC, be familiar with the clinical characteristics and prognosis of disease development, and understand the relevant monitoring and follow-up strategies for the prevention and treatment of PLC. Currently, there are few large, single-center cohort studies on the clinical features and long-term prognosis of PLC.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date August 31, 2024
Est. primary completion date August 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. 18 years or older; 2. initial diagnosis of primary liver cancer based on enhanced CT or enhanced MRI or pathology Exclusion Criteria: 1. other types of malignant tumors; 2. mental illness, severe cardiopulmonary dysfunction, severe renal insufficiency, serious infection and cerebrovascular accident; 3. received liver transplant or other organ transplant.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Nanjing Drum Tower Hospital Nanjing Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Epidemiological characteristics of overall cohort by liver disease etiology Epidemiological characteristics of overall cohort by liver disease etiology, including HBV, HCV, NAFLD, ALD and others. 0 year
Primary Clinical characteristics of overall cohort by liver disease etiology Clinical characteristics of overall cohort by liver disease etiology, including HBV, HCV, NAFLD, ALD and others. 0 year
Secondary Survival rates of overall cohort and different etiologies 1-year, 3-year, 5-year, and 10-year survival rates for overall cohort and different etiologies 1 year, 3years,10 years
Secondary Risk factors of prognosis in overall cohort and different etiologies Risk factors for recurrence, metastasis, and all cause death in overall cohort and different etiologies 10 years
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