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Clinical Trials in China / NCT07147335
Recruiting Observational

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

NCT07147335 · tracked via the Priya Life Science China tracker
Sponsor
The First Affiliated Hospital of University of South China
Phase
Observational
Started
2025-05-16
Last updated
2025-08-29

Condition(s) studied

CirrhosisHepotacellular Carcinoma

Investigational drug(s) / intervention(s)

serum AKR1B10 levels

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

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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)

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
University of South China Hengyang Hunan Recruiting

More The First Affiliated Hospital of University of South China trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07147335 on ClinicalTrials.gov ↗ ← All trials in China