Clinical Intervention Strategy for High-risk Group of Hepatitis B Related Hepatocellular Carcinoma

May 4, 2022 updated by: Zhang Dazhi,MD

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. Follow up: after enrollment, the relevant examination indexes were rechecked every 3 months. The follow-up period was 3 years.
  6. Patients with new liver diseases and decompensated complications of liver cirrhosis also need to be recorded.

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hepatitis B patients who meet the inclusion conditions and do not meet the exclusion conditions。

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Long term follow-up
No extra intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The patients' enrollment time.
Time Frame: up to 3 years.
The time of all patients when they were enrolled.
up to 3 years.
Time the patients were diagnosed.
Time Frame: up to 5 years
The time of the patients when they were diagnosed of liver cancer.
up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhang Dazhi,MD

Collaborators

The Affiliated Hospital Of Southwest Medical University
Chongqing Public Health Medical Center
Chongqing Three Gorges Central Hospital

Investigators

  • Principal Investigator: Dazhi Zhang, Doctor, The Second Affiliated Hospital of Chongqing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 10, 2022

Primary Completion (Anticipated)

December 15, 2024

Study Completion (Anticipated)

December 15, 2024

Study Registration Dates

First Submitted

January 6, 2022

First Submitted That Met QC Criteria

February 16, 2022

First Posted (Actual)

February 25, 2022

Study Record Updates

Last Update Posted (Actual)

May 9, 2022

Last Update Submitted That Met QC Criteria

May 4, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Zhangdz2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no sharing plan

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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