Serum AKR1B10 as an early-warning marker for hepatocellular carcinoma in cirrhosis
The Role of Serum AKR1B10 in Early Warning of Hepatocellular Carcinoma in Cirrhosis Patients ------ Risk Early Warning and Follow-up Study
This study will test whether a blood test for AKR1B10 can help detect early liver cancer in adults with cirrhosis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 800 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital of University of South China Academic / other |
| Locations | 1 site (Hengyang, Hunan) |
| Trial ID | NCT07147335 on ClinicalTrials.gov |
What this trial studies
This is a prospective multicenter cohort enrolling adults with liver cirrhosis or chronic hepatitis who do not have diagnosed hepatocellular carcinoma. Participants will have serial blood draws for serum AKR1B10 alongside standard surveillance including imaging and AFP measurements and will be followed for malignant transformation. Investigators will compare AKR1B10 performance alone and combined with existing risk prediction models to determine whether it improves early detection sensitivity. The goal is to develop a high-sensitivity early diagnostic strategy suitable for clinical implementation.
Who should consider this trial
Good fit: Adults aged 18–75 with diagnosed liver cirrhosis or chronic hepatitis who do not have known hepatocellular carcinoma and can provide informed consent and follow-up are ideal candidates.
Not a fit: Patients already diagnosed with HCC, those who are pregnant or lactating, have severe uncontrolled systemic disease, or cannot complete follow-up are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, using serum AKR1B10 could enable earlier detection of hepatocellular carcinoma in people with cirrhosis, allowing earlier treatment and potentially better outcomes.
How similar studies have performed: Smaller and single-center studies have reported elevated AKR1B10 in very small tumor nodules, suggesting promise, but large prospective multicenter validation remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Hengyang, Hunan
- University of South China — Hengyang, Hunan, China (Recruiting)
Study contacts
- Study coordinator: Xi Zeng, PhD
- Email: xzeng@usc.edu.cn
- Phone: 17773486769
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.