Evaluation of AKR1B10 as a New Marker for Interventional Therapy of Hepatocellular Carcinoma

NCT06272656 | Recruiting DMC

• 1 other identifier: AKR-TACE-001
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Primary liver cancer is currently the fourth most common malignant tumor and the second leading cause of tumor mortality in China, posing a serious threat to the lives and health of the Chinese people . At present, non-surgical treatment methods are often used, such as radiofrequency ablation (RFA), Transcatheter arterial chemoembolization (TACE), radiation therapy, and systemic anti-tumor therapy. However, whether it is surgical treatment or non-surgical treatment, commonly used liver cancer related biomarkers in clinical practice during the evaluation of treatment efficacy or regular follow-up of patients include AFP, AFP-L3%, DCP, etc. , but there are no reports on whether AKR1B10 can be used for the efficacy evaluation of these treatment methods.Therefore, this project aims to explore the clinical value of AKR1B10 in evaluating the efficacy of liver cancer treatment.

Conditions

Hepatocellular Carcinoma

Keywords

AKR1B10

Outcome Measures

Primary Outcomes (1)

• comparison of liver cancer markers AKR1B10, AFP, AFP-L3% and DCP before and after TACE

  Liver cancer markers AKR1B10, AFP, AFP-L3 and DCP are measured before TACE, 1 month and 3 months after TACE in order to evaluate the course of these markers after the intervention

  baseline, 1 month and 3 months

Secondary Outcomes (2)

• long-term survival (1-year, 3-year, 5-year)

  up to 5 years

• progression- free - time

  up to 5 years

Study Arms (1)

HCC Patients treated with TACE

HCC patients who have received initial diagnosis and treatment in our hospital and are planning to receive TACE.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All participants have signed an informed consent form, agreeing that their samples and related information can be used for all medical studies.

You may qualify if:

• age between 18 and 80
• diagnosis of HCC according the AASLD criteria
• TACE is planned
• resection is impossible
• No significant underlying medical illness affecting patient's survival
• Patients available for regular follow-up according to the study protocol

You may not qualify if:

• Previous history of other tumors;
• Combined with other tumors;
• Received external treatment before admission;
• Patients who have received blood transfusions within one month;
• The patient was unable to participate in this study for other reasons.

Sponsors & Collaborators

• Hebei Medical University Third Hospital: lead

Study Sites (1)

HebeiMUTH

Shijiazhuang, Hebei, 050000, China

RECRUITING

Related Publications (7)

• Zhou M, Wang H, Zeng X, Yin P, Zhu J, Chen W, Li X, Wang L, Wang L, Liu Y, Liu J, Zhang M, Qi J, Yu S, Afshin A, Gakidou E, Glenn S, Krish VS, Miller-Petrie MK, Mountjoy-Venning WC, Mullany EC, Redford SB, Liu H, Naghavi M, Hay SI, Wang L, Murray CJL, Liang X. Mortality, morbidity, and risk factors in China and its provinces, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2019 Sep 28;394(10204):1145-1158. doi: 10.1016/S0140-6736(19)30427-1. Epub 2019 Jun 24.

  PMID: 31248666 BACKGROUND

• Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.

  PMID: 30207593 BACKGROUND

• Zhu XD, Huang C, Shen YH, Ji Y, Ge NL, Qu XD, Chen L, Shi WK, Li ML, Zhu JJ, Tan CJ, Tang ZY, Zhou J, Fan J, Sun HC. Downstaging and Resection of Initially Unresectable Hepatocellular Carcinoma with Tyrosine Kinase Inhibitor and Anti-PD-1 Antibody Combinations. Liver Cancer. 2021 Jul;10(4):320-329. doi: 10.1159/000514313. Epub 2021 Mar 30.

  PMID: 34414120 BACKGROUND

• Wang Z, Ren Z, Chen Y, Hu J, Yang G, Yu L, Yang X, Huang A, Zhang X, Zhou S, Sun H, Wang Y, Ge N, Xu X, Tang Z, Lau W, Fan J, Wang J, Zhou J. Adjuvant Transarterial Chemoembolization for HBV-Related Hepatocellular Carcinoma After Resection: A Randomized Controlled Study. Clin Cancer Res. 2018 May 1;24(9):2074-2081. doi: 10.1158/1078-0432.CCR-17-2899. Epub 2018 Feb 2.

  PMID: 29420221 BACKGROUND

• Tateishi R, Shiina S, Yoshida H, Teratani T, Obi S, Yamashiki N, Yoshida H, Akamatsu M, Kawabe T, Omata M. Prediction of recurrence of hepatocellular carcinoma after curative ablation using three tumor markers. Hepatology. 2006 Dec;44(6):1518-27. doi: 10.1002/hep.21408.

  PMID: 17133456 RESULT

• Yoo J, Lee MW, Lee DH, Lee JH, Han JK. Evaluation of a serum tumour marker-based recurrence prediction model after radiofrequency ablation for hepatocellular carcinoma. Liver Int. 2020 May;40(5):1189-1200. doi: 10.1111/liv.14406. Epub 2020 Mar 13.

  PMID: 32056353 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.

  PMID: 30672601 RESULT

Related Links

• Pubmed

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum samples from liver cancer patients at 4 ℃, 4000g, centrifuge for 10 minutes, and take 500 samples μ Place L in a 1.5mL EP tube and freeze at -80 ℃ for later use.

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Yuemin Nan

  Hebei Medical University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuemin Nan

CONTACT

17835683894; Hb20231221@163.com

Pei Guo

CONTACT

17835683894; G545632518@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Hepatology Department of integrated Chinese and Western Medicine

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: February 22, 2024
• Study Start: April 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: June 30, 2025
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)