NCT07147335Recruiting
The Role of Serum AKR1B10 in Early Warning of Hepatocellular Carcinoma in Cirrhosis Patients
The Role of Serum AKR1B10 in Early Warning of Hepatocellular Carcinoma in Cirrhosis Patients ------ Risk Early Warning and Follow-up Study
Source: ClinicalTrials.gov · Last updated 29 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 800 (estimated)
- First submitted
- 12 Aug 2025
- Start date
- 16 May 2025
- Primary completion date
- 31 Mar 2028
- Lead sponsor
- The First Affiliated Hospital of University of South China
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07147335
What you commit to
- Study type: Observational
- Planned participants: 800
- From 16 May 2025 to the primary completion date, 31 Mar 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Lost to follow-up prior to reaching the observational endpoints
- Concurrent severe systemic diseases (e.g., involving cardiovascular, cerebral, pulmonary, renal, or hematopoietic systems)
Age
- Aged \<18 years or \>75 years
Other
- Pregnancy or lactation
- Incomplete clinical data, serological or imaging records
- Current or recent (within 3 months) participation in other clinical trials
- Diagnosed with hepatocellular carcinoma (HCC)
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of South China Coordinator of this site? Confirm its status | Hengyang | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.