Ignite Creation Date:
2024-05-06 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05738772
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-02-22
First Post:
2023-02-12
Brief Title:
Diagnostic Accuracy of APAC ASAP and GALAD Scores in Hepatocellular Carcinoma Among Cirrhotic Patients
Sponsor:
Sohag University
Organization:
Sohag University
Study Overview
Official Title:
Diagnostic Accuracy of APAC ASAP and GALAD Scores in Hepatocellular Carcinoma Among Cirrhotic Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-02
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:
Hepatocellular carcinoma HCC is the most common primary liver malignancy with most patients developing HCC due to chronic liver diseases Unfortunately HCC has a morality to incidence ratio that approaches 1
Among the etiological factors associated with HCC hepatitis C virus HCV and Hepatitis B virus HBV infections are major risk factors Despite HBV vaccination programs and effective direct antiviral agents DAA for treatment of HCV the incidence of virus-related HCC remains high HCV eradication by antiviral treatment reduces but does not eliminate HCC risk Patients with HCV-related cirrhosis require HCC surveillance even after sustained virologic response SVR due to a persistent risk of HCC even years after SVR In Egypt HCC represents the fourth common cancer and is the most common cause of mortality-related and morbidity-related cancer Egypt ranks the third and 15th most populous country in Africa and worldwide respectively and the Egyptian health authorities consider HCC as one of the most challenging health problems for the current decade Both HCC screening and monitoring efforts have improved significantly since 2018 as a result of the national screening campaign The early diagnosis of HCC is essential to initiate curative treatments to improve short term and long-term prognosis Therefore highly effective methods are needed to detect HCC at an earlier stage American Association for the Study of Liver Diseases AASLD and European Association for the Study of the Liver EASL guidelines recommend the periodic use of ultrasound scanning USS with or without Alpha-fetoprotein AFP evaluation for HCC surveillance However suboptimal performance of USS has been reported with its sensitivity being compromised by the extent of liver cirrhosis high body mass index BMI etiology of liver disease expertise of the operator and quality of the equipment Moreover its sensitivity and specificity for early-stage HCC was found to be rather low Serum biomarkers play an essential role in diagnosing HCC as biomarkers are often more convenient inexpensive non-invasive and reproducible Alpha-fetoprotein AFP is a widely used biomarker for HCC diagnosis The diagnostic accuracy of AFP is limited however due to its high false-negative rate to detect small or early stage tumors As previous studies have demonstrated the sensitivity of AFP among patients with HCC was 52 for tumors 3cm and dropped to only 25 for tumors 3cm In addition AFP may also be elevated in some benign liver diseases such as chronic hepatitis and cirrhosis even in the absence of HCC
Among the etiological factors associated with HCC hepatitis C virus HCV and Hepatitis B virus HBV infections are major risk factors Despite HBV vaccination programs and effective direct antiviral agents DAA for treatment of HCV the incidence of virus-related HCC remains high HCV eradication by antiviral treatment reduces but does not eliminate HCC risk Patients with HCV-related cirrhosis require HCC surveillance even after sustained virologic response SVR due to a persistent risk of HCC even years after SVR In Egypt HCC represents the fourth common cancer and is the most common cause of mortality-related and morbidity-related cancer Egypt ranks the third and 15th most populous country in Africa and worldwide respectively and the Egyptian health authorities consider HCC as one of the most challenging health problems for the current decade Both HCC screening and monitoring efforts have improved significantly since 2018 as a result of the national screening campaign The early diagnosis of HCC is essential to initiate curative treatments to improve short term and long-term prognosis Therefore highly effective methods are needed to detect HCC at an earlier stage American Association for the Study of Liver Diseases AASLD and European Association for the Study of the Liver EASL guidelines recommend the periodic use of ultrasound scanning USS with or without Alpha-fetoprotein AFP evaluation for HCC surveillance However suboptimal performance of USS has been reported with its sensitivity being compromised by the extent of liver cirrhosis high body mass index BMI etiology of liver disease expertise of the operator and quality of the equipment Moreover its sensitivity and specificity for early-stage HCC was found to be rather low Serum biomarkers play an essential role in diagnosing HCC as biomarkers are often more convenient inexpensive non-invasive and reproducible Alpha-fetoprotein AFP is a widely used biomarker for HCC diagnosis The diagnostic accuracy of AFP is limited however due to its high false-negative rate to detect small or early stage tumors As previous studies have demonstrated the sensitivity of AFP among patients with HCC was 52 for tumors 3cm and dropped to only 25 for tumors 3cm In addition AFP may also be elevated in some benign liver diseases such as chronic hepatitis and cirrhosis even in the absence of HCC
Detailed Description:
None
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