Use of Blood Biomarkers for the Early Diagnosis of Hepatocellular Carcinoma (HCC)

Status: Recruiting

Location: See location...

Intervention Type: Diagnostic test

Study Type: Observational

SUMMARY

The objective of this observational study is to evaluate the clinical utility of the combined assay of 3 biomarkers: α-FP, α-FP-L3 and DCP (simultaneously measured by µTASWakoTM i30 automated in vitro diagnostic system) in high-risk subjects to develop this neoplasm. In particular, it aims to: * Evaluate the clinical utility of the combined use of α-FP, α-FP-L3 and DCP in predicting the onset of HEPATOCARCINOMA (HCC); * Evaluate the performance of GALAD and GALADUS scores in the early diagnosis of HCC; * Evaluate the association between the levels of the three biomarkers (individually and in combination with each other) and the stage of HCC

Eligibility

Participation Requirements

Sex: All

Healthy Volunteers: f

View:

• Case Group:

⁃ Patients with HCC first diagnosed from cirrhosis or other aetiology

• Controls group:

⁃ Candidate patients for HCC surveillance, with liver cirrhosis and chronic hepatitis of any etiology without HCC seen at our institution

Locations

Other Locations

Italy

RCCS Saverio de Bellis

RECRUITING

Castellana Grotte

Contact Information

Primary

Endrit Shahini, MD

endrit.shahini@irccsdebellis.it

00390804994249

Backup

Raffaele Cozzolongo, MD

raffaele.cozzolongo@irccsdebellis.it

00390804994249

Time Frame

Start Date: 2023-02-24

Estimated Completion Date: 2025-01-27

Participants

Target number of participants: 60

Treatments

Control Group

The control group will be composed of patients who will be candidates for HCC surveillance, i.e. those with liver cirrhosis or chronic hepatitis of any aetiology without HCC seen at our institution.~Included in this group are:~1. Patients newly enrolled and who will be tested for α-FP, α-FP-L3%, and DCP as part of their regular follow-up;~2. Patients who had previously given consent for the storage of a serum sample in the Biobank and who had authorized the dosage of α-FP, α-FP-L3% and DCP.

Case Group

The case group will be composed of patients with newly diagnosed HCC in the context of cirrhosis or any other aetiology during the same study period. This group will include:~1. Patients newly enrolled and who will be tested for α-FP, α-FP-L3%, and DCP as part of their regular follow-up;~2. Patients who had previously given consent for the storage of a serum sample in the Biobank and who had authorized the dosage of α-FP, α-FP-L3% and DCP at the time of tumor diagnosis.

Related Therapeutic Areas

Cirrhosis

Non-Alcoholic Fatty Liver Disease

Liver Cancer

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Use of Blood Biomarkers for the Early Diagnosis of Hepatocellular Carcinoma (HCC)

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