About this trial
Hepatocellular carcinoma (HCC) is a globally prevalent malignancy. In its characteristic "chronic hepatitis-liver cirrhosis-HCC" progression trilogy, patients with cirrhosis demonstrate a 5-year HCC incidence rate of 3%-5%, yet effective monitoring strategies remain lacking. Current early diagnosis relies on the combination of imaging techniques and serum alpha-fetoprotein (AFP), but AFP measurements are frequently confounded by pregnancy and liver diseases, resulting in suboptimal sensitivity and specificity. In recent years, novel tumor biomarkers such as AKR1B10 (Aldo-keto reductase family 1 member B10) have been examined. This multicenter prospective cohort study aims to validate the predictive value of serum AKR1B10 for malignant transformation in cirrhosis-HCC progression, and evaluate its combined efficacy with existing risk prediction models, ultimately establishing a high-sensitivity early diagnostic strategy for clinical implementation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Meets diagnostic criteria for liver cirrhosis and chronic hepatitis
Aged 18-75 years, regardless of gender
Willing to participate in the study and provides signed informed consent
Has not participated in other clinical trials within the last 3 months
Disqualifiers
Pregnancy or lactation
Incomplete clinical data, serological or imaging records
Lost to follow-up prior to reaching the observational endpoints
Aged <18 years or >75 years
Trial population
Patients with Hepatitis and Liver Cirrhosis
Trial design
Cohort
Prospective
Treatments tested in this trial
serum AKR1B10 levels
Diagnostic testInvestigators collected blood from the patients every three months to test their serum AKR1B10 levels.
Treatment groups
Trial outcomes
Primary outcomes
HCC
In this clinical trial, all patients with cirrhosis underwent ultrasound and serum AKR1B10 tests every three months
Sponsors and contacts
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