Clinical trial NCT06272656: Evaluation of AKR1B10 as a New Marker for Interventional Therapy of Hepatocellular Carcinoma
Official title: Evaluation of AKR1B10 as a New Marker for Interventional Therapy of Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatocellular Carcinoma
Keywords: AKR1B10
Lead sponsor: Hebei Medical University Third Hospital
Sponsor class: OTHER
First posted: 2024-02-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: comparison of liver cancer markers AKR1B10, AFP, AFP-L3% and DCP before and after TACE
timeFrame: baseline, 1 month and 3 months
Secondary outcomes:
measure: long-term survival (1-year, 3-year, 5-year)
timeFrame: up to 5 years
measure: progression- free - time
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Shijia Zhuang
country: China
facility: HebeiMUTH
state: Hebei
Study officials:
affiliation: Hebei Medical University Third Hospital
name: Yuemin Nan
role: PRINCIPAL_INVESTIGATOR
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