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NCT Number: NCT07147335

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

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.

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Key information

Conditions

Cirrhosis Fibrosis Hepotacellular Carcinoma Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of South China

Hengyang, Hunan, 421001, China

Location status: Recruiting

Location contact

Xi Zeng, PhD

CONTACT

[email protected]

17773486769

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

serum AKR1B10 levels

Diagnostic Test

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

Primary outcomes

  1. HCC

    Time frame: 36 mouths

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

Study contacts

Contact information is provided by the study sponsor or research team.

Xi Zeng, PhD

CONTACT

[email protected]

17773486769

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of University of South China

Other

Registry information

Official study title

The Role of Serum AKR1B10 in Early Warning of Hepatocellular Carcinoma in Cirrhosis Patients ------ Risk Early Warning and Follow-up Study

Acronym: AKR1B10

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Aug 29, 2025
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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