Carcinoma, HepatocellulardSEARCHNCT05870969
Digitalized Surveillance Management for Liver Cancer Risk Population in Improving Eearly Diagnosis Efficancy in Chinese Population (dSEARCH)
An observational study of Carcinoma, Hepatocellular and Hepatitis C, Chronic, run by Ruijin Hospital at 1 site in China.
Trial summary
The goal of this study is to evaluate whether the standardized liver cancer risk stratification management can effectively improve the early diagnosis rate of liver cancer in the targeted risk population in China. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Carcinoma, Hepatocellular, Hepatitis C, Chronic, Hepatitis B, Chronic
- What is being tested?
- Liver cancer surveillance every 3 months, Liver cancer surveillance every 6 months and Liver cancer surveillance annually
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 20,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to Mar 2028
- 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 study mainly includes the following risk groups of liver cancer: patients with chronic hepatitis B, patients with hepatitis C, patients with liver cirrhosis, patients with metabolic dysfunction-associated fatty liver disease (MAFLD) with a liver fibrosis index F3 or above, MAFLD patients combined with abnormal glucose metabolism, and people with a family history of liver cancer in their first-degree biological relatives.
Who may be able to join
- Voluntary participation in the clinical study; fully informed about the study and signed informed consent, willing to follow and capable of completing all trial procedures[17]
- Age: 18 to 75 years old (including the cut-offs)
- Subjects must meet at least one of the following criteria for enrollment.
- Patients diagnosed with chronic hepatitis B in hospital or out of hospital: persistent positive hepatitis B surface antigen (HBsAg) for 6 months or more
- Patients diagnosed with hepatitis C in hospital or out of hospital
- Patients diagnosed with cirrhosis in hospital or out of hospital who meet at least one of the following criteria.
Show all 16Show fewer
- Liver biopsy showing cirrhosis (Ishak score ≥5 or Metavir score = 4);
- Liver stiffness measurement (LSM) using FibroScan® (Echosens™, Paris, France) ≥12.0 kPa when TB was normal and ALT ≤ 40 IU/mL, or LSM ≥ 17.0 kPa when TB was normal and ALT < 200 IU/mL;
- Abdominal imaging results showing characteristic of cirrhosis (results showing coarse liver echotexture or nodular, parenchymal, or morphological abnormalities and signs of gastroesophageal varices);
- APRI ≥ 2.0;
- FIB-4 ≥ 3.25
- Patients diagnosed with metabolic dysfunction-associated fatty liver disease (MAFLD) in hospital or out of hospital who have a liver fibrosis score of F3 or higher according to transient elastography, i.e., FibroScan® Liver Stiffness Measurement (LSM) ≥ 10 kPa or the corresponding FibroTouch® measurement threshold[18].
- MAFLD diagnosis requires diagnosis of >5% fat accumulation in liver through either FibroScan® CAP measurements, or similar parameter, or liver biopsy, and in combination with one of the following three conditions: overweight/obesity (BMI >23 kg/m2), type 2 diabetes, or metabolic dysfunction.
- Patients diagnosed with MAFLD combined with abnormal glucose metabolism[19]
- Abnormal glucose metabolism is defined as type 2 diabetes, or prediabetes, i.e. fasting blood glucose 5.6-6.9 mmol/L, or 2h postprandial blood glucose 7.8-11.0 mmol/L, or glycated hemoglobin 5.7%-6.4%
- Subjects with a family history of liver cancer in their first-degree biological relatives.
Who cannot join
- Patients meeting any of the following criteria will be excluded from the study:
- Age <18 years or >75 years
- Patients who have been diagnosed with liver cancer before enrollment
- Patients with severe mental illness or cognitive impairment
- Patients who are pregnant or lactating, or preparing to become pregnant
- Patients who have participated in other clinical trials or are participating in other clinical trials within 3 months prior to initiation of study treatment
- According to the doctor's judgment, the possibility of the subject being included is low (including inability to understand the project requirements , poor compliance, infirmity, inability to ensure that the protocol can be implemented as required, etc.), or the doctor determines that the subject has any other factors that are not suitable for this study
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
Department of Infectious Diseases , Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
Qing Xie, MD, PhD., 0086-021-64370045 ext. 680403, xieqingrjh@163.com
Honglian Gui, MD,PhD, 0086-021-64370045 ext. 680419, lillian_ghl@163.com
About this study
Official title: Exploration of A Holistic Management Procedure for Liver Cancer Surveillance in Improving Liver Cancer's Early Diagnosis Efficacy in Chinese Population: Single-Center, Prospective, Observational Real-world Study in EASTERN China
The goal of this study is to evaluate whether the standardized liver cancer risk stratification management can effectively improve the early diagnosis rate of liver cancer in the targeted risk population in China.
- Conditions
- Carcinoma, Hepatocellular, Hepatitis C, Chronic, Hepatitis B, Chronic, Cirrhosis, Liver, Non-Alcoholic Fatty Liver Disease
- Being tested
- Liver cancer surveillance every 3 months, Liver cancer surveillance every 6 months, Liver cancer surveillance annually
- Medical subject headings
- Carcinoma, Hepatocellular, Hepatitis C, Chronic, Hepatitis B, Chronic, Liver Cirrhosis, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver cancer surveillance every 3 monthsBehavioural
Follow up every 3 months for liver cancer surveillance, including but not limited to serum AFP test and ultrasound exam
Liver cancer surveillance every 6 monthsBehavioural
Follow up every 6 months for liver cancer surveillance, including but not limited to serum AFP test and ultrasound exam
Liver cancer surveillance annuallyBehavioural
Follow up annually for liver cancer surveillance, including but not limited to serum AFP test and ultrasound exam
| Study group | Role | What they receive |
|---|---|---|
| Patients with very high risk for HCC according local guideline | Not described Receives: Behavioral: Liver cancer surveillance every 3 months | |
| Patients with high risk for HCC according local guideline | Not described Receives: Behavioral: Liver cancer surveillance every 3 months | |
| Patients with medium risk for HCC according local guideline | Not described Receives: Behavioral: Liver cancer surveillance every 6 months | |
| Patients with low risk for HCC according local guideline | Not described Receives: Behavioral: Liver cancer surveillance annually |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early diagnosis rate of HCC patients
The proportion of patients who are first diagnosed with HCC at early stage to all the patients diagnosed as liver cancer in the study, from the start of the study to the completion of follow-up. Early diagnosis is defined as the patient with stage CNLC Ia, Ib and IIa.
Measured: Follow up up to three years for HCC occurance.
Secondary outcomes (6)
Proportion of subjects with regular follow-up
Regular follow-up is defined as the average difference between the actual treatment time and the theoretical treatment time equal or less than 1/3
- Actual visit interval: actual visit date - previous visit date ② Theoretical visit interval: theoretical visit date (the date that physician advise to return to hospital for visit) - previous visit date ③ Follow-up compliance = (②-①)/② ④ Patient with regular follow-up is defined as the patient whose mean follow-up compliance is equal to, or less than 1/3
- The compliance of the study is defined as the proportion of subjects with regular follow-up to all subjects in the study.
Measured: Four years collectively after the study started
The distribution of risk stratification of liver cancer in subjects at initial screening
The proportion of very high-risk, high-risk, medium-risk, and low-risk subjects to the whole subject population
Measured: Initial screening after enrollment
The distribution of risk stratification of liver cancer in subjects at the last follow-up visit or at the time of diagnosis of liver cancer
The proportion of very high-risk, high-risk, medium-risk and low-risk subjects to the whole subject population
Measured: Last follow-up visit or at the time of diagnosis of liver cancer up to three years of follow-up
Pooled 3-year cumulative incidence of liver cancer
Measured: Follow up up to 3 years
The early diagnosis rate of liver cancer in each subject category according to the risk stratification at initial screening
The early diagnosis rate of liver cancer of subjects with very high-risk, high-risk, medium-risk, and low-risk at initial screening, respectively
Measured: Initial screening after enrollment
The 3-year cumulative incidence of liver cancer in each subject category according to the risk stratification at the time of initial diagnosis
The 3-year cumulative incidence of liver cancer for subjects with very high-risk, high-risk, medium-risk, and low-risk, respectively
Measured: Four years collectively after the study started
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start1 Mar 2023
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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
- Prospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qing XIe, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05870969
- Sponsor's protocol ID
- dSEARCH
- Acronym
- dSEARCH
- Status last verified
- May 2023
- First submitted
- 13 May 2023
- Last updated
- 23 May 2023
- 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 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of A Holistic Management Procedure for Liver Cancer Surveillance in Improving Liver Cancer's Early Diagnosis Efficacy in Chinese Population: Single-Center, Prospective, Observational Real-world Study in EASTERN China
- ClinicalTrials.gov ID
- NCT05870969
- Acronym / sponsor ID
- dSEARCH / dSEARCH
- Conditions
- Carcinoma, Hepatocellular, Hepatitis C, Chronic, Hepatitis B, Chronic, Cirrhosis, Liver, Non-Alcoholic Fatty Liver Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 23 May 2023 (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.
The goal of this study is to evaluate whether the standardized liver cancer risk stratification management can effectively improve the early diagnosis rate of liver cancer in the targeted risk population in China.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients with very high risk for HCC according local guideline | – | Behavioral: Liver cancer surveillance every 3 months |
| Patients with high risk for HCC according local guideline | – | Behavioral: Liver cancer surveillance every 3 months |
| Patients with medium risk for HCC according local guideline | – | Behavioral: Liver cancer surveillance every 6 months |
| Patients with low risk for HCC according local guideline | – | Behavioral: Liver cancer surveillance annually |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study mainly includes the following risk groups of liver cancer: patients with chronic hepatitis B, patients with hepatitis C, patients with liver cirrhosis, patients with metabolic dysfunction-associated fatty liver disease (MAFLD) with a liver fibrosis index F3 or above, MAFLD patients combined with abnormal glucose metabolism, and people with a family history of liver cancer in their first-degree biological relatives.
Key inclusion criteria (16 listed)
- Voluntary participation in the clinical study; fully informed about the study and signed informed consent, willing to follow and capable of completing all trial procedures[17]
- Age: 18 to 75 years old (including the cut-offs)
- Subjects must meet at least one of the following criteria for enrollment.
Key exclusion criteria (7 listed)
- Age <18 years or >75 years
- Patients who have been diagnosed with liver cancer before enrollment
- Patients with severe mental illness or cognitive impairment
- Patients who are pregnant or lactating, or preparing to become pregnant
- Patients who have participated in other clinical trials or are participating in other clinical trials within 3 months prior to initiation of study treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liver cancer surveillance every 3 monthsFollow up every 3 months for liver cancer surveillance, including but not limited to serum AFP test and ultrasound exam | Behavioural | Patients with high risk for HCC according local guideline, Patients with very high risk for HCC according local guideline |
| Liver cancer surveillance every 6 monthsFollow up every 6 months for liver cancer surveillance, including but not limited to serum AFP test and ultrasound exam | Behavioural | Patients with medium risk for HCC according local guideline |
| Liver cancer surveillance annuallyFollow up annually for liver cancer surveillance, including but not limited to serum AFP test and ultrasound exam | Behavioural | Patients with low risk for HCC according local guideline |
Primary outcome
Early diagnosis rate of HCC patients
Time frame: Follow up up to three years for HCC occurance.
The proportion of patients who are first diagnosed with HCC at early stage to all the patients diagnosed as liver cancer in the study, from the start of the study to the completion of follow-up. Early diagnosis is defined as the patient with stage CNLC Ia, Ib and IIa.
6 secondary outcomes
Proportion of subjects with regular follow-up
Time frame: Four years collectively after the study started
The distribution of risk stratification of liver cancer in subjects at initial screening
Time frame: Initial screening after enrollment
The distribution of risk stratification of liver cancer in subjects at the last follow-up visit or at the time of diagnosis of liver cancer
Time frame: Last follow-up visit or at the time of diagnosis of liver cancer up to three years of follow-up
Pooled 3-year cumulative incidence of liver cancer
Time frame: Follow up up to 3 years
The early diagnosis rate of liver cancer in each subject category according to the risk stratification at initial screening
Time frame: Initial screening after enrollment
The 3-year cumulative incidence of liver cancer in each subject category according to the risk stratification at the time of initial diagnosis
Time frame: Four years collectively after the study started
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 23 May 2023.
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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 Carcinoma, Hepatocellular and Hepatitis C, Chronic, run by Ruijin Hospital 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 16 inclusion and 7 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 23 May 2023. 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 Qing Xie, MD (0086-021-64370045 ext. 680403, xieqingrjh@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 HCC patients (time frame: Follow up up to three years for HCC occurance.). 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 23 May 2023.