Liver Cancer (Primary and Metastatic)NCT07820644
A Cohort Study (Risk Prediction of HCC in Patients With Chronic Liver Disease)
An observational study of Liver Cancer (Primary and Metastatic), run by Cai Qingxian at 1 site in China.
Trial summary
Evaluating the effectiveness of standardized HCC risk stratification management in improving early diagnosis rates in patients with chronic liver disease Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Cancer (Primary and Metastatic)
- How many people
- 15,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to 31 Mar 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a single-arm, observational cohort study. The target liver disease patients include those with chronic hepatitis B virus infection, hepatitis C virus infection, liver cirrhosis, metabolic dysfunction-associated fatty liver disease (MAFLD) with a liver fibrosis index of F3 or above, alcoholic liver disease, MAFLD with abnormal glucose metabolism, and those with a first-degree family history of hepatocellular carcinoma. Based on the number of such patients at Shenzhen Third People's Hospital within one case year, this study plans to enroll 15,000 subjects.
Who may be able to join
- Voluntarily participate in the clinical study, fully understand and be informed of this study, sign the informed consent form, be willing to comply with and have the ability to complete all trial procedures.
- Age between 18 and 75 years (inclusive)
- Enrolled subjects must meet at least one of the following conditions: [1] Diagnosed with chronic hepatitis B virus infection via in-hospital or out-of-hospital pathways: Hepatitis B surface antigen (HBsAg) positive for 6 months or more; [2] Diagnosed with chronic hepatitis C virus infection via in-hospital or out-of-hospital pathways; [3] Subjects with a first-degree family history of hepatocellular carcinoma (first-degree relatives: parents, children, and full siblings);[4]Diagnosed with liver cirrhosis via in-hospital or out-of-hospital pathways, and meeting at least one of the following criteria: a) Liver biopsy showing cirrhosis (Ishak score ≥ 5 or Metavir score = 4); b) Liver Stiffness Measurement (LSM) assessed by FibroScan ® (Echosens™, Paris, France) ≥ 12.0 kPa with normal total bilirubin (TB) and ALT ≤ 40 IU/mL, or LSM ≥ 17.0 kPa with normal TB and ALT < 200 IU/mL; c) Abdominal imaging findings indicative of cirrhosis (i.e., liver with a coarse texture or with echoes or showing nodularity, parenchymal or morphological abnormalities, and signs of gastroesophageal varices); d) APRI score ≥ 2.0; e) FIB-4 index ≥ 3.25; [5] Diagnosed with metabolic dysfunction-associated fatty liver disease (MAFLD) via in-hospital or out-of-hospital pathways and with moderate liver fibrosis, specifically defined as a liver fibrosis score of F3 or above based on transient elastography, i.e., FibroScan® LSM ≥ 10 kPa or the corresponding threshold for FibroTouch® [24]; or non-invasive liver fibrosis index FIB-4 > 3.25; or NFS > 0.67; or APRI > 1. • The diagnosis of metabolic dysfunction-associated fatty liver disease (MAFLD) requires evidence of >5% hepatic steatosis based on the Controlled Attenuation Parameter (CAP) from transient elastography, or similar parameters, or liver biopsy, concurrently with at least one of the following three conditions: overweight/obesity (BMI > 23 kg/m²), type 2 diabetes, or evidence of metabolic dysregulation. [6] Diagnosed with metabolic dysfunction-associated fatty liver disease (MAFLD) complicated by glucose metabolism abnormalities via in-hospital or out-of-hospital pathways: a) Glucose metabolism abnormality is defined as type 2 diabetes, or prediabetes indicated by fasting plasma glucose 5.6-6.9 mmol/L, or 2-hour postprandial glucose 7.8-11.0 mmol/L, or glycated hemoglobin (HbA1c) 5.7%-6.4%
Who cannot join
- Age < 18 years or > 75 years
- Suffering from severe mental illness or cognitive impairment
- Pregnant or breastfeeding patients, or patients planning to become pregnant
- Individuals who have participated in another clinical trial within the last 3 months or are currently participating in another clinical trial
- Individuals deemed by the physician to have a low likelihood of enrollment (including inability to understand project requirements, poor compliance, frailty, inability to ensure the protocol can be followed as required, etc.), or those whom the physician considers to have other factors making them unsuitable for this trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Third People's Hospital of Shenzhen
Shenzhen, Guangdong, 518000
Cai, Doctor, 13696020717, gdm4726@163.com
About this study
Official title: A Single-center, Open-label, Single-arm, Observational Cohort Study on Early Diagnosis and Risk Prediction of Hepatocellular Carcinoma in Patients With Chronic Liver Disease Based on a Digital Management Platform
Evaluating the effectiveness of standardized HCC risk stratification management in improving early diagnosis rates in patients with chronic liver disease
Read the detailed description
This study is a single-center, open-label, single-arm, observational cohort study. Patients with liver disease who visit the Department of Hepatology or related departments (such as Liver Oncology, Hepatitis and Cirrhosis, Complicated and Severe Liver Diseases, Hepatobiliary Surgery, Infectious Diseases, and Geriatrics) will be directly recommended for enrollment by their attending physicians based on the inclusion and exclusion criteria. The study mainly consists of four components: HCC screening, HCC diagnosis, HCC risk stratification, and HCC surveillance follow-up. After enrollment, patients will undergo an initial HCC screening. Those with abnormal screening results will proceed to the HCC diagnostic process and undergo staging according to the China Liver Cancer Staging (CNLC) system. Patients with normal screening results or confirmed non-HCC will be classified into four groups based on their risk of developing HCC (very high risk, high risk, moderate risk, and low risk), and will be assigned corresponding follow-up surveillance protocols, with periodic HCC screening and risk stratification. A high-risk cohort will be established for long-term follow-up observation over three years, with sample retention performed when necessary.
- Conditions
- Liver Cancer (Primary and Metastatic)
- Medical subject headings
- Liver Neoplasms, Neoplasm Metastasis
What is being measured
The primary outcome is the main question the study is designed to answer.
Early diagnosis rate of hepatocellular carcinoma (HCC)
The proportion of participants diagnosed with HCC at an early stage from project initiation until completion of follow-up, defined as the percentage of patients with CNLC stages Ia, Ib, and IIa among all participants with HCC detected in this study.
Measured: Through study completion, an average of 3 years
Secondary outcomes (1)
Proportion of participants with regular follow-up
Regular follow-up is defined as the mean follow-up adherence being less than 1/3. Definitions: ① Actual visit interval: time of current visit minus time of previous visit. ② Scheduled visit interval: scheduled return visit time (as prescribed at the previous visit) minus time of the previous visit. ③ Follow-up adherence = (1-①/②)/2. The proportion of participants with regular follow-up is defined as the number of participants who meet the criteria for regular follow-up divided by the total.
Measured: Through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start1 Jun 2026
- Primary completion31 Mar 2030 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Cancer (Primary and Metastatic)Studies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 15,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cai Qingxian
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cai Qingxian, Shenzhen Third People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07820644
- Sponsor's protocol ID
- KY2026-057
- Status last verified
- Sep 2026
- First submitted
- 10 Apr 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open-label, Single-arm, Observational Cohort Study on Early Diagnosis and Risk Prediction of Hepatocellular Carcinoma in Patients With Chronic Liver Disease Based on a Digital Management Platform
- ClinicalTrials.gov ID
- NCT07820644
- Acronym / sponsor ID
- KY2026-057
- Conditions
- Liver Cancer (Primary and Metastatic)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- Cai QingxianUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 31 Mar 2030 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 15 Sep 2026 (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.
Evaluating the effectiveness of standardized HCC risk stratification management in improving early diagnosis rates in patients with chronic liver disease
Detailed description
This study is a single-center, open-label, single-arm, observational cohort study. Patients with liver disease who visit the Department of Hepatology or related departments (such as Liver Oncology, Hepatitis and Cirrhosis, Complicated and Severe Liver Diseases, Hepatobiliary Surgery, Infectious Diseases, and Geriatrics) will be directly recommended for enrollment by their attending physicians based on the inclusion and exclusion criteria. The study mainly consists of four components: HCC screening, HCC diagnosis, HCC risk stratification, and HCC surveillance follow-up. After enrollment, patients will undergo an initial HCC screening. Those with abnormal screening results will proceed to the HCC diagnostic process and undergo staging according to the China Liver Cancer Staging (CNLC) system. Patients with normal screening results or confirmed non-HCC will be classified into four groups based on their risk of developing HCC (very high risk, high risk, moderate risk, and low risk), and will be assigned corresponding follow-up surveillance protocols, with periodic HCC screening and risk stratification. A high-risk cohort will be established for long-term follow-up observation over three years, with sample retention performed when necessary.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a single-arm, observational cohort study. The target liver disease patients include those with chronic hepatitis B virus infection, hepatitis C virus infection, liver cirrhosis, metabolic dysfunction-associated fatty liver disease (MAFLD) with a liver fibrosis index of F3 or above, alcoholic liver disease, MAFLD with abnormal glucose metabolism, and those with a first-degree family history of hepatocellular carcinoma. Based on the number of such patients at Shenzhen Third People's Hospital within one case year, this study plans to enroll 15,000 subjects.
Key inclusion criteria (3 listed)
- Voluntarily participate in the clinical study, fully understand and be informed of this study, sign the informed consent form, be willing to comply with and have the ability to complete all trial procedures.
- Age between 18 and 75 years (inclusive)
- Enrolled subjects must meet at least one of the following conditions: [1] Diagnosed with chronic hepatitis B virus infection via in-hospital or out-of-hospital pathways: Hepatitis B surface antigen (HBsAg) positive for 6 months or more; [2] Diagnosed with chronic hepatitis C virus infection via in-hospital or out-of-hospital pathways; [3] Subjects with a first-degree family history of hepatocellular carcinoma (first-degree relatives: parents, children, and full siblings);[4]Diagnosed with liver cirrhosis via in-hospital or out-of-hospital pathways, and meeting at least one of the following criteria: a) Liver biopsy showing cirrhosis (Ishak score ≥ 5 or Metavir score = 4); b) Liver Stiffness Measurement (LSM) assessed by FibroScan ® (Echosens™, Paris, France) ≥ 12.0 kPa with normal total bilirubin (TB) and ALT ≤ 40 IU/mL, or LSM ≥ 17.0 kPa with normal TB and ALT < 200 IU/mL; c) Abdominal imaging findings indicative of cirrhosis (i.e., liver with a coarse texture or with echoes or showing nodularity, parenchymal or morphological abnormalities, and signs of gastroesophageal varices); d) APRI score ≥ 2.0; e) FIB-4 index ≥ 3.25; [5] Diagnosed with metabolic dysfunction-associated fatty liver disease (MAFLD) via in-hospital or out-of-hospital pathways and with moderate liver fibrosis, specifically defined as a liver fibrosis score of F3 or above based on transient elastography, i.e., FibroScan® LSM ≥ 10 kPa or the corresponding threshold for FibroTouch® [24]; or non-invasive liver fibrosis index FIB-4 > 3.25; or NFS > 0.67; or APRI > 1. • The diagnosis of metabolic dysfunction-associated fatty liver disease (MAFLD) requires evidence of >5% hepatic steatosis based on the Controlled Attenuation Parameter (CAP) from transient elastography, or similar parameters, or liver biopsy, concurrently with at least one of the following three conditions: overweight/obesity (BMI > 23 kg/m²), type 2 diabetes, or evidence of metabolic dysregulation. [6] Diagnosed with metabolic dysfunction-associated fatty liver disease (MAFLD) complicated by glucose metabolism abnormalities via in-hospital or out-of-hospital pathways: a) Glucose metabolism abnormality is defined as type 2 diabetes, or prediabetes indicated by fasting plasma glucose 5.6-6.9 mmol/L, or 2-hour postprandial glucose 7.8-11.0 mmol/L, or glycated hemoglobin (HbA1c) 5.7%-6.4%
Key exclusion criteria (5 listed)
- Age < 18 years or > 75 years
- Suffering from severe mental illness or cognitive impairment
- Pregnant or breastfeeding patients, or patients planning to become pregnant
- Individuals who have participated in another clinical trial within the last 3 months or are currently participating in another clinical trial
- Individuals deemed by the physician to have a low likelihood of enrollment (including inability to understand project requirements, poor compliance, frailty, inability to ensure the protocol can be followed as required, etc.), or those whom the physician considers to have other factors making them unsuitable for this trial
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
Early diagnosis rate of hepatocellular carcinoma (HCC)
Time frame: Through study completion, an average of 3 years
The proportion of participants diagnosed with HCC at an early stage from project initiation until completion of follow-up, defined as the percentage of patients with CNLC stages Ia, Ib, and IIa among all participants with HCC detected in this study.
1 secondary outcome
Proportion of participants with regular follow-up
Time frame: Through study completion, an average of 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No
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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.
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 Liver Cancer (Primary and Metastatic), run by Cai Qingxian 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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 15 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dongmei Gou, Dr (+8613696020717, gdm4726@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early diagnosis rate of hepatocellular carcinoma (HCC) (time frame: Through study completion, an average of 3 years). 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 15 Sep 2026.