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

NCT05256459 | Unknown

• 1 other identifier: Zhangdz2017
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Time

Outcome Measures

Primary Outcomes (2)

• The patients' enrollment time.

  The time of all patients when they were enrolled.

  up to 3 years.

• Time the patients were diagnosed.

  The time of the patients when they were diagnosed of liver cancer.

  up to 5 years

Study Arms (2)

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

Interventions

Long term follow-up OTHER

No extra intervention.

Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhang Dazhi,MD: lead
• Chongqing Three Gorges Central Hospital: collaborator
• The Affiliated Hospital Of Southwest Medical University: collaborator
• Chongqing Public Health Medical Center: collaborator

Study Officials

• Dazhi Zhang, Doctor

  The Second Affiliated Hospital of Chongqing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Linhan Li, Master

CONTACT

17623676495; 741789028@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 6, 2022
• First Posted: February 25, 2022
• Study Start: May 10, 2022
• Primary Completion: December 15, 2024
• Study Completion: December 15, 2024
• Last Updated: May 9, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share