Cirrhosis, Hepotacellular Carcinoma
Conditions
Keywords
AKR1B10, Hepotacellular carcinoma, cirrhosis
Brief summary
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.
Detailed 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.
Interventions
DIAGNOSTIC_TESTserum AKR1B10 levels
Investigators collected blood from the patients every three months to test their serum AKR1B10 levels.
Sponsors
The First Affiliated Hospital of University of South China
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HCC | 36 mouths | In this clinical trial, all patients with cirrhosis underwent ultrasound and serum AKR1B10 tests every three months |
Countries
China
Contacts
Primary ContactXi Zeng, PhD
Outcome results
None listed