Clinical trial NCT06325267: Clinical Characteristics of Primary Liver Cancer
Official title: A Single Center, Retrospective Clinical Study on the Clinical Characteristics of Primary Liver Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Primary Liver Cancer
Keywords: primary liver cancer
clinical features
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary liver cancer

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Epidemiological characteristics of overall cohort by liver disease etiology
timeFrame: 0 year
measure: Clinical characteristics of overall cohort by liver disease etiology
timeFrame: 0 year
Secondary outcomes:
measure: Survival rates of overall cohort and different etiologies
timeFrame: 1 year, 3years，10 years
measure: Risk factors of prognosis in overall cohort and different etiologies
timeFrame: 10 years
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
Study officials:
References: