The Role of Serum AKR1B10 in Early Warning of Hepatocellular Carcinoma in Cirrhosis Patients

The First Affiliated Hospital of University of South China

Status

Enrolling

Conditions

Cirrhosis

Hepotacellular Carcinoma

Treatments

Diagnostic Test: serum AKR1B10 levels

Study type

Observational

Funder types

Other

Identifiers

NCT07147335

AKR1B10's clinical study

Details and patient eligibility

About

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.

Full description

Patients with liver cirrhosis and chronic hepatitis were enrolled in this clinical trial. The study was designed to investigate the clinical value of serum AKR1B10 in hepatocellular carcinoma (HCC) risk prediction, early diagnosis, and screening among individuals with cirrhosis. Previous studies have demonstrated elevated AKR1B10 levels in small tumor nodules measuring <2 cm. Based on these findings, Investigators hypothesize that in a subset of cirrhotic patients, hepatic tissues may harbor ultra-early carcinogenic or precancerous lesions undetectable by current clinical modalities, and that serum AKR1B10 could serve as an early warning signal for such occult malignant transformation.

Enrollment

800 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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
Concurrent severe systemic diseases (e.g., involving cardiovascular, cerebral, pulmonary, renal, or hematopoietic systems)
Current or recent (within 3 months) participation in other clinical trials
Diagnosed with hepatocellular carcinoma (HCC)