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

Plain Language Summary

Simplified for easier understanding

This study is testing whether a blood protein called AKR1B10 can serve as an early warning sign for liver cancer (hepatocellular carcinoma, or HCC) in people who already have liver cirrhosis (scarring of the liver). **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with liver cirrhosis or chronic hepatitis - You are willing to participate and sign a consent form - You have not participated in another clinical trial in the past 3 months **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have already been diagnosed with liver cancer (HCC) - You have serious diseases affecting your heart, brain, lungs, kidneys, or blood system - Your medical records are incomplete Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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