Primary Liver CancerNCT06325267
Clinical Characteristics of Primary Liver Cancer
An observational study of Primary Liver Cancer, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Liver Cancer
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2010to 31 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: primary liver cancer
Who may be able to join
- 18 years or older;
- initial diagnosis of primary liver cancer based on enhanced CT or enhanced MRI or pathology
Who cannot join
- other types of malignant tumors;
- mental illness, severe cardiopulmonary dysfunction, severe renal insufficiency, serious infection and cerebrovascular accident;
- received liver transplant or other organ transplant.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008
Jie Li, M.D., Ph.D, 15863787910, lijier@nju.edu.cn
About this study
Official title: 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.
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.
- Conditions
- Primary Liver Cancer
- Keywords
- primary liver cancer, clinical features
- Medical subject headings
- Carcinoma, Hepatocellular
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 0 year
Secondary outcomes (2)
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
Measured: 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
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start1 Jan 2010
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Liver CancerStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jie Li, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06325267
- Sponsor's protocol ID
- PLC
- Status last verified
- Mar 2024
- First submitted
- 15 Mar 2024
- Last updated
- 27 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Retrospective Clinical Study on the Clinical Characteristics of Primary Liver Cancer
- ClinicalTrials.gov ID
- NCT06325267
- Acronym / sponsor ID
- PLC
- Conditions
- Primary Liver Cancer
- Keywords
- primary liver cancer, clinical features
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 22 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary liver cancer
Key inclusion criteria (2 listed)
- 18 years or older;
- initial diagnosis of primary liver cancer based on enhanced CT or enhanced MRI or pathology
Key exclusion criteria (3 listed)
- other types of malignant tumors;
- mental illness, severe cardiopulmonary dysfunction, severe renal insufficiency, serious infection and cerebrovascular accident;
- received liver transplant or other organ transplant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Epidemiological characteristics of overall cohort by liver disease etiology
Time frame: 0 year
Epidemiological characteristics of overall cohort by liver disease etiology, including HBV, HCV, NAFLD, ALD and others.
Clinical characteristics of overall cohort by liver disease etiology
Time frame: 0 year
Clinical characteristics of overall cohort by liver disease etiology, including HBV, HCV, NAFLD, ALD and others.
2 secondary outcomes
Survival rates of overall cohort and different etiologies
Time frame: 1 year, 3years，10 years
Risk factors of prognosis in overall cohort and different etiologies
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
Related trials for Primary Liver Cancer
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
Not yet recruitingObservational study
Immune-Related Adverse Events and Clinical Outcomes of First-Line Immunotherapy in Egyptian Patients With Unresectable Hepatocellular Carcinoma
Hepatocellular Carcinoma, Hepatocellular Carcinoma (HCC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Liver Cancer, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jie Li, M.D.,Ph.D (15863787910, lijier@nju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epidemiological characteristics of overall cohort by liver disease etiology (time frame: 0 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2024.