The Role of Serum AKR1B10 in Early Warning of Hepatocellular Carcinoma in Cirrhosis Patients

NCT07147335 | Recruiting

• 1 other identifier: AKR1B10's clinical study
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Cirrhosis; Hepotacellular Carcinoma

Keywords

AKR1B10; Hepotacellular carcinoma; cirrhosis

Outcome Measures

Primary Outcomes (1)

• HCC

  In this clinical trial, all patients with cirrhosis underwent ultrasound and serum AKR1B10 tests every three months

  36 mouths

Study Arms (2)

The serum AKR1B10 concentration was high in patients with cirrhosis.

The serum AKR1B10 concentration was high in patients with cirrhosis.

Diagnostic Test: serum AKR1B10 levels

The serum AKR1B10 concentration was low in patients with cirrhosis

The serum AKR1B10 concentration was low in patients with cirrhosis

Diagnostic Test: serum AKR1B10 levels

Interventions

serum AKR1B10 levels DIAGNOSTIC_TEST

Investigators collected blood from the patients every three months to test their serum AKR1B10 levels.

The serum AKR1B10 concentration was high in patients with cirrhosis.; The serum AKR1B10 concentration was low in patients with cirrhosis

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Hepatitis and Liver Cirrhosis

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The First Affiliated Hospital of University of South China: lead

Study Sites (1)

University of South China

Hengyang, Hunan, 421001, China

RECRUITING

Related Publications (8)

• 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.

  PMID: 38619448 BACKGROUND

• 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.

  PMID: 33734139 BACKGROUND

• 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.

  PMID: 26078578 BACKGROUND

• 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.

  PMID: 29395269 BACKGROUND

• 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.

  PMID: 22729709 BACKGROUND

• 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.

  PMID: 30672601 BACKGROUND

• 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.

  PMID: 33579421 BACKGROUND

• Zhu AX. Hepatocellular carcinoma: are we making progress? Cancer Invest. 2003 Jun;21(3):418-28. doi: 10.1081/cnv-120018233.

  PMID: 12901288 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

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.

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Xi Zeng, PhD

CONTACT

17773486769; xzeng@usc.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Director

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 29, 2025
• Study Start: May 16, 2025
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)