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Clinical study for risk factors of hepatocellular carcinoma during antiviral therapy in patients with chronic HBV infection cohort

Clinical study for risk factors of hepatocellular carcinoma during antiviral therapy in patients with chronic HBV infection cohort

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000028881
Enrollment
Unknown
Registered
2020-01-05
Start date
2022-02-01
Completion date
Unknown
Last updated
2020-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic viral hepatitis b

Interventions

HCC group vs. non-HCC group:Nil

Sponsors

Tianjin Third Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Gender not limited, aged >= 18 years; 2. The patient met the chronic viral diagnosis of b, i.e., HBsAg positive for more than 6 months and hbv-dna positive (higher than 1000copies/ml or 200IU/ml); 3. Data integrity: the onset age, gender, family history, baseline virology indicators ((HBSAg, anti - HBS, HBeAg, anti - HBe, anti - HBc, HBV DNA), treatment records, baseline virology treatment process indicators ((HBSAg, anti - HBS, HBeAg, anti - HBe, anti - HBc, HBV DNA), HBV DNA, liver function, AFP and imaging data (abdominal B to exceed, upper abdomen (strengthen), liver ultrasound CT angiography, liver stiffness, etc.), the patient, the patient outcome traceability. 4. In the event of primary liver cancer, hepatitis b combined primary liver cancer diagnosis standard: 1) Have hepatitis b or hepatitis b cirrhosis of the liver, 2 cm or less on nodules, dynamic enhanced MRI, dynamic enhanced CT and ultrasound imaging and the beauty show dynamic enhanced magnetic resonance imaging (MRI) at least two out of four examination showed arterial lesions significantly improved, portal or delay improved falling fast in fast out of the typical features of liver cancer;For nodules with an intrahepatic diameter of > 2cm, as long as one of the above four imaging examinations has typical characteristics of liver cancer, it can be clinically diagnosed as liver cancer. 2) Any liver biopsy suggesting primary liver cancer.

Exclusion criteria

Exclusion criteria: 1. Patients with primary liver cancer at the beginning of the study; 2. Severe underlying diseases, including uncontrolled clinically significant heart, lung, kidney, digestive, neurological, psychiatric, immune, metabolic or other malignancies. 3. Patients who cannot obtain blood samples; 4. Hepatitis b with secondary malignant tumor of the liver.

Design outcomes

Primary

MeasureTime frame
HBsAg;HBCrAg;HBVRNA;HBV DNA;M2BPGi;HBVx gene subtype;

Countries

China

Contacts

Public ContactHuiling Xiang

Gastroenterology Department, Tianjin Third Central Hospital

huilingxiang@163.com+86 15522242920

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026