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A multicenter study evaluating the efficacy of the GADA model in the auxiliary diagnosis of early primary liver cancer

A multicenter study evaluating the efficacy of the GADA model in the auxiliary diagnosis of early primary liver cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500108299
Enrollment
Unknown
Registered
2025-08-27
Start date
2025-08-31
Completion date
Unknown
Last updated
2025-09-01

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

Conditions

Primary liver cancer Liver cirrhosis Liver fibrosis Chronic hepatitis B Chronic hepatitis C Alcoholic liver disease Non-alcoholic steatohepatitis Autoimmune hepatitis

Interventions

Index test:GADA Hepatocellular Carcinoma Risk Assessment Model
Gold Standard:The clinical diagnostic criteria for patients with primary liver cancer refer to the "Diagnosis and Treatment Guidelines for Primary Liver Cancer (2024 Edition)".

Sponsors

Shandong Provincial Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Liver cancer group (experimental group) : 1. Age 18 years old and above, gender not limited; 2. Patients clinically diagnosed with HCC and confirmed by radiology or liver biopsy; 3. The staging information of liver cancer is clear. The staging of liver cancer was scored using the Chinese Liver Cancer Staging Protocol (CNLC). Stage I is the early stage, stage II is the middle stage, stage III is the advanced stage, and stage IV is the terminal stage. Chronic liver disease (control group) : 1. Age 18 years old and above, gender not limited; 2. Clinically diagnosed as chronic hepatitis B, chronic hepatitis C, alcoholic hepatitis, non-alcoholic steatohepatitis, autoimmune hepatitis, liver fibrosis, liver cirrhosis, etc. 3. For some patients suspected of having liver cancer, it is necessary to confirm the absence of HCC through imaging results within 12 months before enrollment.

Exclusion criteria

Exclusion criteria: 1.Subjects who meet any of the following conditions will not be eligible to participate in this study: 1. Presenting as an uncertain liver mass or a liver mass that meets the radiological criteria of HCC; 2. Any other form of cancer (excluding melanoma skin cancer); 3. Recurrent HCC, having undergone or currently undergoing HCC treatment; 4. The glomerular filtration rate of the patient was less than 60 mL/min/1.73 m2; 5. Currently undergoing anti-vitamin K coagulation therapy (such as warfarin, phenylpropofol or asenocortol); 6. Those with a history of transplantation of major functional organs; 7. The subject has a clinical and laboratory-proven history of pancreatitis, or has presented clinical or laboratory manifestations related to the current pancreatitis; 8. Other circumstances where the researcher deems it unsuitable for inclusion in the group.

Design outcomes

Primary

MeasureTime frame
Alpha-fetoprotein(AFP)?Protein Induced by Vitamin K Absence or Antagonist-II(PIVKA-II)?Golgi Protein 73(GP73);Accuracy;Sensitivity;Specificity;

Countries

China

Contacts

Public ContactZhuangXuewei

Shandong Provincial Third Hospital

15288869381@163.com+86 531 8165 6669

Outcome results

None listed

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