RecruitingNCT07147335

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

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


Sponsor

The First Affiliated Hospital of University of South China

Enrollment

800 participants

Start Date

May 16, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria4

  • 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 Criteria7

  • 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)

Interventions

DIAGNOSTIC_TESTserum AKR1B10 levels

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


Locations(1)

University of South China

Hengyang, Hunan, China

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NCT07147335


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