MedTrace Logo

Diagnostic Accuracy of APAC, ASAP and GALAD Scores in Hepatocellular Carcinoma Among Cirrhotic Patients

NCT05738772 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 90

Last updated 2023-02-22

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

serum sample for ELIZA

Assay of AFP, AFP-L3, DCP and Soluble PDGFRβwill be done by enzyme-linked immunosorbent assay (ELISA).

Sponsors & Collaborators

  • Sohag University

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-15
Primary Completion
2024-03-31
Completion
2024-03-31

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05738772 on ClinicalTrials.gov