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

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

NCT ID: NCT05738772

Condition: Hepatocellular Carcinoma

Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular

Study type: Observational

Overall status: Not yet recruiting

Study design:

Time perspective: Cross-Sectional

Intervention:

Intervention type: Diagnostic Test
Intervention name: serum sample for ELIZA
Description: Assay of AFP, AFP-L3, DCP and Soluble PDGFRβwill be done by enzyme-linked immunosorbent assay (ELISA).
Arm group label: LC group
Arm group label: hcc group

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.

Criteria for eligibility:

Study pop:
A total of 90 adult patients with liver cirrhosis attending the outpatient clinic or inpatient section of the department of tropical medicine and gastroenterology at Sohag University Hospital will be included in the study. Patients will be divided into two groups.:

Sampling method: Non-Probability Sample
Criteria:
Inclusion Criteria: - A total of 90 adult patients with liver cirrhosis attending the outpatient clinic or inpatient section of the department of tropical medicine and gastroenterology at Sohag University Hospital will be included in the study. Patients will be divided into two groups Exclusion Criteria: - 1. patients aged <18 years old. 2. Presence of clinically suspected other causes of hepatocellular injury (any history of alcoholism, autoimmune hepatitis, primary sclerosing cholangitis (PSC), primary biliary cholangitis (PBC), Wilson's disease, fatty liver diseases with metabolic syndrome & drug induced liver disease). 3. Receipt of any tumor specific therapy before blood samples collection. 4. Any patients who are on warfarin will be excluded as warfarin can elevate the DCP level in the absence of HCC. 5. Patients having malignancies other than HCC. 6. Presence of distant metastasis. 7. Presence of venous thromboembolism including portal vein thrombosis

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Sohag University Hospital

Address:
City: Sohag
Country: Egypt

Contact:
Last name: Magdy M Amin, professor

Start date: February 15, 2023

Completion date: March 2024

Lead sponsor:
Agency: Sohag University
Agency class: Other

Source: Sohag University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05738772