Clinical Characteristics of Primary Liver Cancer

A Single Center, Retrospective Clinical Study on the Clinical Characteristics of Primary Liver Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Primary Liver Cancer

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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Jie Li, M.D.,Ph.D; Phone Number: 15863787910; Email: lijier@nju.edu.cn
• Study Contact Backup: Name: Qianqian Chen; Phone Number: 18360722012; Email: qian_1395692197@126.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Recruiting
      • Nanjing Drum Tower Hospital
      • Contact: Jie Li, M.D., Ph.D; Phone Number: 15863787910; Email: lijier@nju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

primary liver cancer

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: March 15, 2024
• First Submitted That Met QC Criteria: March 15, 2024
• First Posted (Actual): March 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: clinical features; primary liver cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms
• Other Study ID Numbers: PLC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No