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

February 12, 2023 updated by: Sara Mahmoud Mohammed Mohammed, Sohag University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Khairy H Morsy, Professor

Study Locations

  • Egypt
      • Sohag, Egypt
        • Sohag University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.:

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
hcc group
The study group will include 45 patients with HCC on top of liver cirrhosis. All virus-related liver cirrhosis and all BCLC stages of HCC will be accepted. Verified presence of HCC, will be assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) or based on histological validation. In patients with presence of liver cirrhosis, non-invasive diagnosis of HCC is standard, when dynamic imaging shows typical diagnostic patterns as the combination of hypervascularity in late arterial phase and washout on portal venous and/or delayed phases
Diagnostic test: serum sample for ELIZA
Assay of AFP, AFP-L3, DCP and Soluble PDGFRβwill be done by enzyme-linked immunosorbent assay (ELISA).
LC group
Will include 45 patients diagnosed with liver cirrhosis on top of HCV or HBV with an absence of focal lesions on ultrasound screening as a control group. Cirrhosis will be determined according to clinical, serological, and radiological findings
Diagnostic test: serum sample for ELIZA
Assay of AFP, AFP-L3, DCP and Soluble PDGFRβwill be done by enzyme-linked immunosorbent assay (ELISA).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum level of AFP-L3.
Time Frame: one year

Assay of AFP-L3 will be done by enzyme-linked immunosorbent assay (ELISA) then Diagnostic scoring tools were calculated using the following formulae:The GALAD score will be calculated using the following equation: GALAD score = - 10.08 + 0.09 × age + 1.67 × gender + 2.34 × Lg (AFP [ng/ml]) + 0.04 × AFP-L3%% + 1.33 × Lg (PIVKA-II [mAU/ml]), where gender = 0 for females and 1 for males. - The probability of HCC in a patient was calculated as follows: Pr (HCC)=exp (Z)/ (1 + exp (Z)) (z: GALAD)The ASAP score was calculated using the following equation: ASAP score = -7.58 + 0.05

× age - 0.58 × gender +0.42 × Ln (AFP [ng/ml]) + 1.11 × Ln (PIVIKA-II [mAU/ml]), where gender = 0 for males and 1 for femalesThe APAC score = (Age [years] x 0.20480) - (log10(sPDGFRβ [pg/mL]) x 1.98684) + (log10(AFP [ng/mL]) x 2.45657) - (Creatinine [mg/dL] x 2.46891) - 4.36493
one year
serum level of DCP
Time Frame: 1 year

Assay of DCP will be done by enzyme-linked immunosorbent assay (ELISA) then Diagnostic scoring tools were calculated using the following formulae:The GALAD score will be calculated using the following equation: GALAD score = - 10.08 + 0.09 × age + 1.67 × gender + 2.34 × Lg (AFP [ng/ml]) + 0.04 × AFP-L3%% + 1.33 × Lg (PIVKA-II [mAU/ml]), where gender = 0 for females and 1 for males. - The probability of HCC in a patient was calculated as follows: Pr (HCC)=exp (Z)/ (1 + exp (Z)) (z: GALAD)The ASAP score was calculated using the following equation: ASAP score = -7.58 + 0.05

× age - 0.58 × gender +0.42 × Ln (AFP [ng/ml]) + 1.11 × Ln (PIVIKA-II [mAU/ml]), where gender = 0 for males and 1 for femalesThe APAC score = (Age [years] x 0.20480) - (log10(sPDGFRβ [pg/mL]) x 1.98684) + (log10(AFP [ng/mL]) x 2.45657) - (Creatinine [mg/dL] x 2.46891) - 4.36493
1 year
Serum level of Soluble PDGFRβ
Time Frame: 1 year

Assay of Soluble PDGFRβ will be done by enzyme-linked immunosorbent assay (ELISA) then Diagnostic scoring tools were calculated using the following formulae:The GALAD score will be calculated using the following equation: GALAD score = - 10.08 + 0.09 × age + 1.67 × gender + 2.34 × Lg (AFP [ng/ml]) + 0.04 × AFP-L3%% + 1.33 × Lg (PIVKA-II [mAU/ml]), where gender = 0 for females and 1 for males. - The probability of HCC in a patient was calculated as follows: Pr (HCC)=exp (Z)/ (1 + exp (Z)) (z: GALAD)The ASAP score was calculated using the following equation: ASAP score = -7.58 + 0.05

× age - 0.58 × gender +0.42 × Ln (AFP [ng/ml]) + 1.11 × Ln (PIVIKA-II [mAU/ml]), where gender = 0 for males and 1 for femalesThe APAC score = (Age [years] x 0.20480) - (log10(sPDGFRβ [pg/mL]) x 1.98684) + (log10(AFP [ng/mL]) x 2.45657) - (Creatinine [mg/dL] x 2.46891) - 4.36493
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 15, 2023

Primary Completion (Anticipated)

March 1, 2024

Study Completion (Anticipated)

March 1, 2024

Study Registration Dates

First Submitted

February 12, 2023

First Submitted That Met QC Criteria

February 12, 2023

First Posted (Estimate)

February 22, 2023

Study Record Updates

Last Update Posted (Estimate)

February 22, 2023

Last Update Submitted That Met QC Criteria

February 12, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-23-02-15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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