Ignite Creation Date:
2024-05-06 @ 11:14 AM
Last Modification Date:
2024-10-26 @ 12:41 PM
Study NCT ID:
NCT03460080
Status:
UNKNOWN
Last Update Posted:
2018-03-09
First Post:
2018-02-12
Brief Title:
Diagnostic Value of AFP-L3 and PIVKA-II in HCC
Sponsor:
Hanoi Medical University
Organization:
Hanoi Medical University
Study Overview
Official Title:
Diagnostic Value of AFP-L3 and PIVKA-II in HCC
Status:
UNKNOWN
Status Verified Date:
2018-03
Last Known Status:
RECRUITING
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:
The incidence of Hepatocellular carcinoma HCC is increasing worldwide However most of HCC cases were at advanced stage when the diagnosis establishedEarly diagnosis improves the prognosisThe study is intended to evaluate the diagnostic efficiency of alpha-fetoprotein-L3 AFP-L3 and Protein Induced by Vitamin K Absence or antagonist-II PIVKA-II This study is performed at Hanoi Medical University Hospital Participants including patients with HCC and hepatic hemangioma All the serum samples are collected before any treatments and will be tested in single center in order to decrease bias Serum samples were tested for PIVKA-II AFP AFP-L3 and biochemical indexes including alanine aminotransferaseALTaspartate aminotransferase AST gamma-glutamyl transferase HbsAg Anti HCV etc
Detailed Description:
Hepatocellular carcinoma HCC is the third leading cause of cancer deaths worldwideEarly diagnosis improves the prognosis Protein induced by vitamin K antagonist-II PIVKA-II also known as des-γ-carboxyprothrombin DCP or acarboxy prothrombin is an abnormal form of prothrombin induced by vitamin K absence or antagonist-II The study is intended to evaluate the diagnostic efficiency of AFP-L3 and PIVKA-II AFP-L3 and PIVKA-II as an effective tumor marker for hepatocellular carcinomaHCC Despite the extensive application of PIVKA-II in some hospitals from Vietnam the diagnostic efficiency including sensitivity specificity positive predictive value and negative predictive value still needs more clinical data to evaluate The research purposes list as follows1 Determination of changes in AFP-L3 and PIVKA II for HCC2 Investigating the diagnostic value of AFP-L3 and PIVKA II for HCC This study is performed at Hanoi Medical University Hospital Participants including patients with HCC and hepatic hemangioma All the serum samples are collected before any treatments and will be tested in single center in order to decrease bias Serum samples were tested for PIVKA-II AFP AFP-L3 and biochemical indexes including alanine aminotransferaseALTaspartate aminotransferase AST gamma-glutamyl transferase HbsAg Anti HCV etcThe diagnosis of HCC was based on HCC criteria of Ministry of Public Health of Vietnam All HCC diagnoses were confirmed at the time of analysis Stages of tumor is evaluated by Barcelana classification The Students t-test or Mann-Whitney test was used to compare continuous variables and the chi-square test or Fishers exact test was used for categorical variables A receiver operator characteristic ROC curve was used to assess the performance characteristic of PIVKA-IIAFPAFP-L3 measurement
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