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RecruitingNCT06325267Updated Mar 27, 2024

Clinical Characteristics of Primary Liver Cancer

An observational study in Primary Liver Cancer, sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-27.

Sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Observational

From the registry’s dates

  • Primary completion was expected by Aug 2024, 2 years 1 month ago, but the record still lists the study as recruiting.
  • Started Jan 2010; still recruiting 16 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,000
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Primary Liver Cancer

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Keywords

  • primary liver cancer
  • clinical features
03

In context

Liver Neoplasms

1,390 studies on the registry are indexed under Liver Neoplasms; 345 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 200 across 350 observational studies indexed under Liver Neoplasms.

Browse Liver Neoplasms studies →

Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School is the lead sponsor of 242 studies on the registry; 144 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

primary liver cancer

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

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.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,000 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 0 year

  2. 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.

    Time frame: 0 year

Secondary outcomes

  1. 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

    Time frame: 1 year, 3years,10 years

  2. 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

    Time frame: 10 years

07

Study locations

1 of 1 sites recruiting
  • Nanjing Drum Tower Hospital
    Nanjing, Jiangsu 210008, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06325267
Lead sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Responsible party
Jie Li (Principal investigator, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School) — Principal investigator
First posted
Mar 22, 2024
Start date
Jan 1, 2010
Primary completion
Aug 31, 2024 (estimated)
Completion
Aug 31, 2024 (estimated)
Last update
Mar 27, 2024

Study contacts

Jie Li, M.D.,Ph.D
Contact
lijier@nju.edu.cn
15863787910
Qianqian Chen
Contact
qian_1395692197@126.com
18360722012

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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