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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorThe First Affiliated Hospital of University of South China

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • serum AKR1B10 levels

    Diagnostic test

    Investigators collected blood from the patients every three months to test their serum AKR1B10 levels.

Treatment groups

800 Participants
are divided into 2 treatment groups
Group A: The serum AKR1B10 concentration was high in patients with cirrhosis.1 intervention
Group B: The serum AKR1B10 concentration was low in patients with cirrhosis1 intervention

Trial outcomes

Primary outcomes

1

HCC

In this clinical trial, all patients with cirrhosis underwent ultrasound and serum AKR1B10 tests every three months

Time frame
36 mouths

Secondary outcomes

Other outcomes

Sponsors and contacts

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