TimeNCT05256459
Clinical Intervention Strategy for High-risk Group of Hepatitis B Related Hepatocellular Carcinoma
An observational study of Time, run by Zhang Dazhi,MD.
Trial summary
This study aims to explore whether there is difference in the incidence rate and incidence rate of HCC in patients with chronic hepatitis B who are screened for high risk of liver cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Time
- What is being tested?
- Long term follow-up
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 10 May 2022to 15 Dec 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
- Adult, Older adult
Study population: Hepatitis B patients who meet the inclusion conditions and do not meet the exclusion conditions。
Who may be able to join
- Willing and able to sign informed consent
- Male or female, 18 ≤ age≤ 75
- The diagnosis was in accordance with the 2019 guidelines for the diagnosis and treatment of chronic hepatitis B and received anti HBV treatment for 48 weeks;
- Imaging examination showed liver nodules or space occupying lesions (any imaging examination of abdominal color Doppler ultrasound, CT and MRI), and imaging examination could not determine the benign and malignant of the lesions
- The estimated survival time is more than half a year
- Peripheral blood cfdna gene screening is high risk
- Full capacity for civil conduct
Who cannot join
- Primary liver cancer was diagnosed or supported by the following evidence: elevated alpha fetoprotein (AFP > 100ng / ml) or liver imaging showed clear liver cancer nodules in the liver
- Have a history of malignant tumors within 5 years before screening, except for specific cancers cured by surgical resection (such as basal cell skin cancer, etc.)
- Current or previous history of major diseases that may interfere with personal treatment, evaluation or compliance. Major diseases are 25 major diseases specified by the CIRC
- Combined with HCV, HIV, HDV or other infectious diseases
- Severe lung disease, severe heart disease or genetic metabolic disease
- Psychiatric hospitalization, attempted suicide and / or temporary disability due to mental illness in the past 5 years
Show all 9Show fewer
- Combined with autoimmune liver disease, alcoholic liver disease and drug-induced liver injury
- Pregnant or lactating women
- The researcher believes that it is not suitable to participate in this experiment.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Intervention Strategy for High-risk Hepatitis B Related Hepatocellular Carcinoma Based on Liquid Biopsy Screening Technique
This study aims to explore whether there is difference in the incidence rate and incidence rate of HCC in patients with chronic hepatitis B who are screened for high risk of liver cancer. Whether the timely intervention can be used to reduce the incidence of HCC for the early screening and early warning patients can provide evidence-based medical evidence for the selection or adjustment of anti HBV drugs in high-risk patients with liver cancer. To provide evidence for whether patients with liver nodules at high risk of liver cancer need to deal with liver nodules in advance.
Read the detailed description
This study is a multicenter, prospective clinical study. Including the Second Affiliated Hospital of Chongqing Medical University, the Third Affiliated Hospital of Chongqing Medical University, the First Affiliated Hospital of Southwest Medical University, Chongqing public health treatment center and the Three Gorges central hospital.
Firstly, patients were screened for peripheral blood cfdna gene to screen patients with high risk of liver cancer. High risk patients were examined for high-precision HBV-DNA quantification, liver function, AFP, abdominal imaging (color Doppler ultrasound, CT or MR), blood map, HIV syphilis screening, anti HDV, anti HCV, etc. according to the results of high-precision HBV-DNA quantification (lower than the detection limit (< 10 IU / ml), ≥ 10 IU / ml, non negative ones are uniformly called positive), and patients are divided into 2 groups according to the wishes of patients, with 50 cases in each group. The observation group includs those who did not deal with nodules and were closely followed up，another group is treatment group，includs those who with hepatic nodules were treated by radiofrequency ablation and/or surgery and so on. Follow up examinations were conducted every 3 months to the center. The follow-up period lasted for 3 years. Clinical data were recorded, incidence rate of liver cancer, occurrence time of liver cancer and incidence of adverse events in liver were recorded.
Research implementation process and route
- Recruitment object: after the approval of the ethics committee, the recruitment was started in each experimental center, the basic information and various examination indexes of the patients were collected, and the patients were informed that they needed to go to the outpatient clinic of our hospital for follow-up examination every 3 months, with a total follow-up of 3 years.
- Establishment of information archives: in addition to recording the basic information and examination results of patients, it also includes the time when patients should be followed up in our hospital. Contact and inform patients in advance before each follow-up time. At the same time, special clinical events during follow-up were recorded.
- Statistical analysis: after a three-year follow-up, the data collected by each center were tested by t-test and multivariate Cox analysis to analyze the time when patients in each group developed into primary liver cancer and the incidence of primary liver cancer in each group.
- Data to be collected: general medical history characteristics: medical record number, name, gender, age, disease degree (whether there is decompensation / compensation of liver cirrhosis, whether there is liver nodule, etc.), enrollment time, contact information, whether to drink alcohol and medication. Examination and inspection indicators: liver function, renal function, blood chart analysis, hepatitis B two half and half, anti HCV, anti HDV, AIDS syphilis screening, high precision HBV-DNA quantification, abdominal color Doppler ultrasound (if necessary CT or MR), liver transient elastography, liver cirrhosis patients need additional coagulation. Patients undergoing radiofrequency ablation or surgical treatment of liver nodules need to record the operation time and mode.
- Follow up: after enrollment, the relevant examination indexes were rechecked every 3 months. The follow-up period was 3 years.
- Patients with new liver diseases and decompensated complications of liver cirrhosis also need to be recorded.
- Conditions
- Time
- Being tested
- Long term follow-up
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long term follow-upOther
No extra intervention.
| Study group | Role | What they receive |
|---|---|---|
| Observation group | Those who did not deal with nodules and were closely followed up. | |
| Treatment group | Patients with liver nodules were treated by radiofrequency ablation or/and surgery and so on. Receives: Other: Long term follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
The patients' enrollment time.
The time of all patients when they were enrolled.
Measured: up to 3 years.
Time the patients were diagnosed.
The time of the patients when they were diagnosed of liver cancer.
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start10 May 2022 (estimated)
- Primary completion15 Dec 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TimeStudies 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhang Dazhi,MD
- Sponsor type
- University, hospital or other
- Collaborators
- Chongqing Three Gorges Central Hospital, The Affiliated Hospital Of Southwest Medical University, Chongqing Public Health Medical Center
- Responsible party
- Sponsor-investigator, Zhang Dazhi,MD, The Second Affiliated Hospital of Chongqing Medical University
- Investigators
- Dazhi Zhang, Doctor, Principal investigator, The Second Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05256459
- Sponsor's protocol ID
- Zhangdz2017
- Status last verified
- May 2022
- First submitted
- 6 Jan 2022
- Last updated
- 9 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no sharing plan
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Intervention Strategy for High-risk Hepatitis B Related Hepatocellular Carcinoma Based on Liquid Biopsy Screening Technique
- ClinicalTrials.gov ID
- NCT05256459
- Acronym / sponsor ID
- Zhangdz2017
- Conditions
- Time
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Zhang Dazhi,MDUniversity, hospital or other
- Collaborators
- Chongqing Three Gorges Central Hospital, The Affiliated Hospital Of Southwest Medical University, Chongqing Public Health Medical Center
- Study start
- 10 May 2022 (estimated)
- Primary completion
- 15 Dec 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 25 Feb 2022 (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.
This study aims to explore whether there is difference in the incidence rate and incidence rate of HCC in patients with chronic hepatitis B who are screened for high risk of liver cancer. Whether the timely intervention can be used to reduce the incidence of HCC for the early screening and early warning patients can provide evidence-based medical evidence for the selection or adjustment of anti HBV drugs in high-risk patients with liver cancer. To provide evidence for whether patients with liver nodules at high risk of liver cancer need to deal with liver nodules in advance.
Detailed description
This study is a multicenter, prospective clinical study. Including the Second Affiliated Hospital of Chongqing Medical University, the Third Affiliated Hospital of Chongqing Medical University, the First Affiliated Hospital of Southwest Medical University, Chongqing public health treatment center and the Three Gorges central hospital.
Firstly, patients were screened for peripheral blood cfdna gene to screen patients with high risk of liver cancer. High risk patients were examined for high-precision HBV-DNA quantification, liver function, AFP, abdominal imaging (color Doppler ultrasound, CT or MR), blood map, HIV syphilis screening, anti HDV, anti HCV, etc. according to the results of high-precision HBV-DNA quantification (lower than the detection limit (< 10 IU / ml), ≥ 10 IU / ml, non negative ones are uniformly called positive), and patients are divided into 2 groups according to the wishes of patients, with 50 cases in each group. The observation group includs those who did not deal with nodules and were closely followed up，another group is treatment group，includs those who with hepatic nodules were treated by radiofrequency ablation and/or surgery and so on. Follow up examinations were conducted every 3 months to the center. The follow-up period lasted for 3 years. Clinical data were recorded, incidence rate of liver cancer, occurrence time of liver cancer and incidence of adverse events in liver were recorded.
Research implementation process and route
- Recruitment object: after the approval of the ethics committee, the recruitment was started in each experimental center, the basic information and various examination indexes of the patients were collected, and the patients were informed that they needed to go to the outpatient clinic of our hospital for follow-up examination every 3 months, with a total follow-up of 3 years.
- Establishment of information archives: in addition to recording the basic information and examination results of patients, it also includes the time when patients should be followed up in our hospital. Contact and inform patients in advance before each follow-up time. At the same time, special clinical events during follow-up were recorded.
- Statistical analysis: after a three-year follow-up, the data collected by each center were tested by t-test and multivariate Cox analysis to analyze the time when patients in each group developed into primary liver cancer and the incidence of primary liver cancer in each group.
- Data to be collected: general medical history characteristics: medical record number, name, gender, age, disease degree (whether there is decompensation / compensation of liver cirrhosis, whether there is liver nodule, etc.), enrollment time, contact information, whether to drink alcohol and medication. Examination and inspection indicators: liver function, renal function, blood chart analysis, hepatitis B two half and half, anti HCV, anti HDV, AIDS syphilis screening, high precision HBV-DNA quantification, abdominal color Doppler ultrasound (if necessary CT or MR), liver transient elastography, liver cirrhosis patients need additional coagulation. Patients undergoing radiofrequency ablation or surgical treatment of liver nodules need to record the operation time and mode.
- Follow up: after enrollment, the relevant examination indexes were rechecked every 3 months. The follow-up period was 3 years.
- Patients with new liver diseases and decompensated complications of liver cirrhosis also need to be recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observation group | – | –Those who did not deal with nodules and were closely followed up. |
| Treatment group | – | Other: Long term follow-upPatients with liver nodules were treated by radiofrequency ablation or/and surgery and so on. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Hepatitis B patients who meet the inclusion conditions and do not meet the exclusion conditions。
Key inclusion criteria (7 listed)
- Willing and able to sign informed consent
- Male or female, 18 ≤ age≤ 75
- The diagnosis was in accordance with the 2019 guidelines for the diagnosis and treatment of chronic hepatitis B and received anti HBV treatment for 48 weeks;
- Imaging examination showed liver nodules or space occupying lesions (any imaging examination of abdominal color Doppler ultrasound, CT and MRI), and imaging examination could not determine the benign and malignant of the lesions
- The estimated survival time is more than half a year
Key exclusion criteria (9 listed)
- Primary liver cancer was diagnosed or supported by the following evidence: elevated alpha fetoprotein (AFP > 100ng / ml) or liver imaging showed clear liver cancer nodules in the liver
- Have a history of malignant tumors within 5 years before screening, except for specific cancers cured by surgical resection (such as basal cell skin cancer, etc.)
- Current or previous history of major diseases that may interfere with personal treatment, evaluation or compliance. Major diseases are 25 major diseases specified by the CIRC
- Combined with HCV, HIV, HDV or other infectious diseases
- Severe lung disease, severe heart disease or genetic metabolic disease
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 |
|---|---|---|
| Long term follow-upNo extra intervention. | Other | Treatment group |
Primary outcome
The patients' enrollment time.
Time frame: up to 3 years.
The time of all patients when they were enrolled.
Time the patients were diagnosed.
Time frame: up to 5 years
The time of the patients when they were diagnosed of liver cancer.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
- Individual participant dataSharing planned: No. There is no sharing plan
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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. This study is not recruiting at the moment.
Dazhi Zhang, Doctor principal investigator
The Second Affiliated Hospital of Chongqing Medical University
Questions about this trial
What is this clinical trial studying?
An observational study of Time, run by Zhang Dazhi,MD.
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 7 inclusion and 9 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 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Linhan Li, Master (17623676495, 741789028@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The patients' enrollment time. (time frame: up to 3 years.). 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 9 May 2022.