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

NCT ID: NCT06272656

Last Updated: 2024-04-30

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2025-06-30

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.

Detailed Description

Patients with hepatocellular carcinoma (HCC) treated with transarterial chemoembolisation (TACE) are enrolled in this clinical trial. In the early stage, a research team detected the levels of AKR1B10 in serum samples from 477 normal individuals, 107 benign liver tumors, 32 patients with chronic hepatitis B, 78 patients with liver cirrhosis, and 482 patients with liver cancer, and evaluated its early diagnostic value in liver cancer. It was found that AKR1B10 protein, as a serum marker for liver cancer, had significantly better performance than AFP, mainly reflected in three aspects: first, it is more sensitive, The normal background level (reference range) of AKR1B10 is significantly lower than AFP, which means that during clinical testing, changes in serum concentration are more pronounced, making it easier to identify asymptomatic early liver cancer patients; Secondly, it is more specific and has a higher detection rate for liver cancer, with lower false positive and false negative rates. In addition, more than 70% of liver cancer patients who test negative for AFP will be tested positive for AKR1B10, resulting in lower rates of missed diagnosis and misdiagnosis; Thirdly, the time to reflect changes in the condition is 6-7 times faster than AFP. The half-life of AKR1B10 is 23 hours, while AFP has a half-life of 6-7 days.This project mainly aims to explore the clinical value of AKR1B10 in evaluating the efficacy of liver cancer treatment.

Conditions

Hepatocellular Carcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

HCC Patients treated with TACE

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hebei Medical University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yuemin Nan

Director of Hepatology Department of integrated Chinese and Western Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yuemin Nan

Role: PRINCIPAL_INVESTIGATOR

Hebei Medical University Third Hospital

Locations

HebeiMUTH

Shijiazhuang, Hebei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yuemin Nan

Role: CONTACT

Hb20231221@163.com

17835683894

Pei Guo

Role: CONTACT

G545632518@163.com

17835683894

Facility Contacts

Yuemin Nan

Role: primary

Hb20231221@163.com

+8633188602489

Pei Guo

Role: backup

G545632518@163.com

17835683894

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Provided Documents

Document Type: Study Protocol and Informed Consent Form

View Document

Related Links

https://pubmed.ncbi.nlm.nih.gov

Pubmed

Other Identifiers

AKR-TACE-001

Identifier Type: -

Identifier Source: org_study_id