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

Sponsor
The First Affiliated Hospital of University of South China
Study ID
NCT07147335
Status
Recruiting
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Conditions

  • Cirrhosis
  • Hepotacellular Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Aug 29, 2025
Start date
May 16, 2025
Status verified
Aug 2025
Primary completion
Mar 31, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
800 participants (estimated)

Arms

  • Arm: The serum AKR1B10 concentration was high in patients with cirrhosis.
    The serum AKR1B10 concentration was high in patients with cirrhosis.
  • Arm: The serum AKR1B10 concentration was low in patients with cirrhosis
    The serum AKR1B10 concentration was low in patients with cirrhosis

Primary Outcome Measure

HCC [ Time Frame: 36 mouths ]

Central Contacts

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