NCT07147335 The Role of Serum AKR1B10 in Early Warning of Hepatocellular Carcinoma in Cirrhosis Patients
| NCT ID | NCT07147335 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The First Affiliated Hospital of University of South China |
| Condition | Cirrhosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 800 participants |
| Start Date | 2025-05-16 |
| Primary Completion | 2028-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 800 participants in total. It began in 2025-05-16 with a primary completion date of 2028-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07147335 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Cirrhosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07147335 currently recruiting?
Yes, NCT07147335 is actively recruiting participants. Contact the research team at xzeng@usc.edu.cn for enrollment information.
Where is the NCT07147335 trial being conducted?
This trial is being conducted at Hengyang, China.
Who is sponsoring the NCT07147335 clinical trial?
NCT07147335 is sponsored by The First Affiliated Hospital of University of South China. The trial plans to enroll 800 participants.