The Role of Serum AKR1B10 in Early Warning of Hepatocellular Carcinoma in Cirrhosis Patients
Recruiting now
Conditions studied: Cirrhosis, Hepotacellular Carcinoma
In brief
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 facts
- Study ID
- NCT07147335
- Run by
- The First Affiliated Hospital of University of South China
- People needed
- 800
- Starts
- 2025-05-16
- Expected to finish
- 2028-03-31
- Last updated by the study team
- 2025-08-29
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- University of South China — Hengyang, Hunan, China (enrolling)
Full record on ClinicalTrials.gov
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