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

April 27, 2024 updated by: Yuemin Nan, Hebei Medical University Third Hospital
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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Hebei
      • Shijia Zhuang, Hebei, China, 050000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
HCC Patients treated with TACE
HCC patients who have received initial diagnosis and treatment in our hospital and are planning to receive TACE.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
comparison of liver cancer markers AKR1B10, AFP, AFP-L3% and DCP before and after TACE
Time Frame: baseline, 1 month and 3 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
long-term survival (1-year, 3-year, 5-year)
Time Frame: up to 5 years
Patients with low AKR1B10 levels have a higher survival rate
up to 5 years
progression- free - time
Time Frame: up to 5 years
Patients with low AKR1B10 levels have a longer progression- free - time
up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hebei Medical University Third Hospital

Investigators

  • Principal Investigator: Yuemin Nan, Hebei Medical University Third Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

January 18, 2024

First Submitted That Met QC Criteria

February 14, 2024

First Posted (Actual)

February 22, 2024

Study Record Updates

Last Update Posted (Estimated)

April 30, 2024

Last Update Submitted That Met QC Criteria

April 27, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AKR-TACE-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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