Viewing Study NCT06272656



Ignite Creation Date: 2024-05-06 @ 8:09 PM
Last Modification Date: 2024-10-26 @ 3:21 PM
Study NCT ID: NCT06272656
Status: RECRUITING
Last Update Posted: 2024-04-30
First Post: 2024-01-18

Brief Title: Evaluation of AKR1B10 as a New Marker for Interventional Therapy of Hepatocellular Carcinoma
Sponsor: Hebei Medical University Third Hospital
Organization: Hebei Medical University Third Hospital

Study Overview

Official Title: Evaluation of AKR1B10 as a New Marker for Interventional Therapy of Hepatocellular Carcinoma
Status: RECRUITING
Status Verified Date: 2024-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 methodsTherefore 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 daysThis project mainly aims to explore the clinical value of AKR1B10 in evaluating the efficacy of liver cancer treatment

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None