Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Patients with liver cirrhosis and chronic hepatitis were enrolled in this clinical trial. The study was designed to investigate the clinical value of serum AKR1B10 in hepatocellular carcinoma (HCC) risk prediction, early diagnosis, and screening among individuals with cirrhosis. Previous studies have demonstrated elevated AKR1B10 levels in small tumor nodules measuring <2 cm. Based on these findings, Investigators hypothesize that in a subset of cirrhotic patients, hepatic tissues may harbor ultra-early carcinogenic or precancerous lesions undetectable by current clinical modalities, and that serum AKR1B10 could serve as an early warning signal for such occult malignant transformation.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The serum AKR1B10 concentration was high in patients with cirrhosis. | The serum AKR1B10 concentration was high in patients with cirrhosis. |
| |
| The serum AKR1B10 concentration was low in patients with cirrhosis | The serum AKR1B10 concentration was low in patients with cirrhosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| serum AKR1B10 levels | Diagnostic Test | Investigators collected blood from the patients every three months to test their serum AKR1B10 levels. |
|
| Measure | Description | Time Frame |
|---|---|---|
| HCC | In this clinical trial, all patients with cirrhosis underwent ultrasound and serum AKR1B10 tests every three months | 36 mouths |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Patients with Hepatitis and Liver Cirrhosis
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xi Zeng, PhD | Contact | 17773486769 | xzeng@usc.edu.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South China | Recruiting | Hengyang | Hunan | 421001 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38619448 | Result | Yeo YH, Lee YT, Tseng HR, Zhu Y, You S, Agopian VG, Yang JD. Alpha-fetoprotein: Past, present, and future. Hepatol Commun. 2024 Apr 12;8(5):e0422. doi: 10.1097/HC9.0000000000000422. eCollection 2024 May 1. | |
| 33734139 | Result | Cao W, Chen HD, Yu YW, Li N, Chen WQ. Changing profiles of cancer burden worldwide and in China: a secondary analysis of the global cancer statistics 2020. Chin Med J (Engl). 2021 Mar 17;134(7):783-791. doi: 10.1097/CM9.0000000000001474. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Biospecimen Description: blood (2 mL) was collected in a plain VACUTAINER tube containing no anticoagulant and allowed to clot at room temperature for 30 minutes, followed by centrifugation at 1,500g for 10 minutes at 4°C to remove clots. Supernatants (serum) were immediately transferred into clean polypropylene tubes (200 µL per tube) using a Pasteur pipette, encoded with a number, and stored or transported at -80°C. Serum samples that were hemolyzed, icteric, or lipemic were excluded.
| 26078578 | Result | Ilikhan SU, Bilici M, Sahin H, Akca AS, Can M, Oz II, Guven B, Buyukuysal MC, Ustundag Y. Assessment of the correlation between serum prolidase and alpha-fetoprotein levels in patients with hepatocellular carcinoma. World J Gastroenterol. 2015 Jun 14;21(22):6999-7007. doi: 10.3748/wjg.v21.i22.6999. |
| 29395269 | Result | Allemani C, Matsuda T, Di Carlo V, Harewood R, Matz M, Niksic M, Bonaventure A, Valkov M, Johnson CJ, Esteve J, Ogunbiyi OJ, Azevedo E Silva G, Chen WQ, Eser S, Engholm G, Stiller CA, Monnereau A, Woods RR, Visser O, Lim GH, Aitken J, Weir HK, Coleman MP; CONCORD Working Group. Global surveillance of trends in cancer survival 2000-14 (CONCORD-3): analysis of individual records for 37 513 025 patients diagnosed with one of 18 cancers from 322 population-based registries in 71 countries. Lancet. 2018 Mar 17;391(10125):1023-1075. doi: 10.1016/S0140-6736(17)33326-3. Epub 2018 Jan 31. |
| 22729709 | Result | Kapoor S. AKR1B10 and its emerging role in tumor carcinogenesis and as a cancer biomarker. Int J Cancer. 2013 Jan 15;132(2):495. doi: 10.1002/ijc.27685. Epub 2012 Jul 30. No abstract available. |
| 30672601 | Result | Ye X, Li C, Zu X, Lin M, Liu Q, Liu J, Xu G, Chen Z, Xu Y, Liu L, Luo D, Cao Z, Shi G, Feng Z, Deng H, Liao Q, Cai C, Liao DF, Wang J, Jin J, Cao D. A Large-Scale Multicenter Study Validates Aldo-Keto Reductase Family 1 Member B10 as a Prevalent Serum Marker for Detection of Hepatocellular Carcinoma. Hepatology. 2019 Jun;69(6):2489-2501. doi: 10.1002/hep.30519. Epub 2019 Apr 6. |
| 33579421 | Result | Chidambaranathan-Reghupaty S, Fisher PB, Sarkar D. Hepatocellular carcinoma (HCC): Epidemiology, etiology and molecular classification. Adv Cancer Res. 2021;149:1-61. doi: 10.1016/bs.acr.2020.10.001. Epub 2020 Nov 28. |
| 12901288 | Result | Zhu AX. Hepatocellular carcinoma: are we making progress? Cancer Invest. 2003 Jun;21(3):418-28. doi: 10.1081/cnv-120018233. |