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CirrhosisAKR1B10NCT07147335

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

An observational study of Cirrhosis and Hepotacellular Carcinoma, run by The First Affiliated Hospital of University of South China at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Cirrhosis, Hepotacellular Carcinoma
What is being tested?
serum AKR1B10 levels
How many people
800 participants
Where
1 siteChina
Study dates
16 May 2025to 31 Mar 2028
How long will I take part?
3 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with Hepatitis and Liver Cirrhosis

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xi Zeng, PhD contact

17773486769

xzeng@usc.edu.cn

China1 site, 1 recruiting

  • University of South China

    Hengyang, Hunan, 421001

    Xi Zeng, PhD, 17773486769, xzeng@usc.edu.cn

    Recruiting

Other trials in China

About this study

Official title: The Role of Serum AKR1B10 in Early Warning of Hepatocellular Carcinoma in Cirrhosis Patients ------ Risk Early Warning and Follow-up Study

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.

Read the detailed description

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.

Being tested
serum AKR1B10 levels
Keywords
AKR1B10, Hepotacellular carcinoma, cirrhosis
Medical subject headings
Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • serum AKR1B10 levelsDiagnostic test

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

Study groups in NCT07147335
Study groupRoleWhat they receive
The serum AKR1B10 concentration was high in patients with cirrhosis.The serum AKR1B10 concentration was high in patients with cirrhosis.
Receives: Diagnostic Test: serum AKR1B10 levels
The serum AKR1B10 concentration was low in patients with cirrhosisThe serum AKR1B10 concentration was low in patients with cirrhosis
Receives: Diagnostic Test: serum AKR1B10 levels

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HCC

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

    Measured: 36 mouths

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2025
  2. Study start16 May 2025
  3. Primary completion31 Mar 2028 (estimated)
  4. Study completion31 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
800 participants (estimated)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT07147335
Sponsor's protocol ID
AKR1B10's clinical study
Acronym
AKR1B10
Status last verified
Aug 2025
First submitted
12 Aug 2025
Last updated
29 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38619448

  • 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.

    PubMed 33734139

  • 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.

    PubMed 26078578

  • 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.

    PubMed 29395269

  • 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.

    PubMed 22729709

  • 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.

    PubMed 30672601

  • 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.

    PubMed 33579421

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

    PubMed 12901288

Questions about this trial

What is this clinical trial studying?

An observational study of Cirrhosis and Hepotacellular Carcinoma, run by The First Affiliated Hospital of University of South China at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xi Zeng, PhD (17773486769, xzeng@usc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HCC (time frame: 36 mouths). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07147335, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.

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