Serum AKR1B10 as an early-warning marker for hepatocellular carcinoma in cirrhosis
Official title: The Role of Serum AKR1B10 in Early Warning of Hepatocellular Carcinoma in Cirrhosis Patients ------ Risk Early Warning and Follow-up Study
Run by The First Affiliated Hospital of University of South China · NCT07147335 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 800 (estimated) |
| Sponsor | The First Affiliated Hospital of University of South China Academic / other |
| Locations | 1 site (Hengyang, Hunan) |
| Status | Recruiting |
| Started | May 16, 2025 |
| Main results expected | March 31, 2028 |
| Study ends | March 31, 2028 |
| Registry record updated | August 29, 2025 |
| Trial ID | NCT07147335 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Smaller and single-center studies have reported elevated AKR1B10 in very small tumor nodules, suggesting promise, but large prospective multicenter validation remains limited.
Who can join: the full rules
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 it's running
-
University of South China
Hengyang, Hunan, China Recruiting
Study contacts
- Study coordinator: Xi Zeng, PhD
- Email: xzeng@usc.edu.cn
- Phone: 17773486769
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Endovascular treatment outcomes after portal hypertension–related GI bleeding in cirrhosis
This study tests how well endovascular procedures for portal hypertension–related GI bleeding work in adults with cirrhosis, and what factors predict outcomes.
-
EUS-guided coil and glue vs glue injection for bleeding gastric varices in cirrhosis
This trial tests whether using endoscopic ultrasound to guide coils plus glue works better than glue alone for stopping bleeding from gastric varices in adults with cirrhosis.
-
4D-Flow MRI to see portal hypertension and TIPS outcomes in cirrhosis
This study tests a noninvasive 4D-Flow MRI method to see if it can safely and reliably reflect portal hypertension and predict outcomes for people with cirrhosis, including those needing a TIPS procedure.
-
Apixaban plus carvedilol to prevent portal-hypertension complications in cirrhosis
This will test whether adding apixaban to carvedilol can help prevent variceal bleeding, portal vein thrombosis, and other portal-hypertension complications in adults with Child-Pugh B cirrhosis.
-
Factors that affect reopening of blocked portal veins in people with cirrhosis and gastroesophageal varices
This project looks at past records and follow-up to see which factors are linked with reopening (recanalization) of blocked portal veins in people who have cirrhosis and endoscopy-confirmed gastroesophageal varices.
-
Copper supplementation for people with cirrhosis
This trial will try giving copper supplements to adults with cirrhosis who have low copper levels or signs of copper deficiency to see if liver-related health improves.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.