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

NCT05781568 | Recruiting

• 1 other identifier: RC202214
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

HCC; Cirrhosis, Liver; NAFLD; HBV; HCV

Keywords

alpha fetoprotein; des-γ-carboxy-prothrombin; α-FP-L3; GALAD; GALADUS

Outcome Measures

Primary Outcomes (1)

• Biomarker dosage

  Determine the GALAD alghoritm (Gender,Age, AFP-L3, AFP and Des-carboxy-prothrombin) by evaluating the values of AFP, AFP-L3, Des-carboxy-prothrombin for each patient, since the GALAD score had a high diagnostic performance as compared to each standalone markers in identifying HCC at any stage.

  six months

Study Arms (2)

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.

Diagnostic Test: Biomarker dosage

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.

Diagnostic Test: Biomarker dosage

Interventions

Biomarker dosage DIAGNOSTIC_TEST

The simultaneous dosage of the 3 serum biomarkers will be performed at the Clinical Pathology Laboratory, using the instrument: µTASWakoTM i30 (Micro Total Analysis System) - Fujifilm.

Case Group; Control Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

To participate in this study, patients belonging to the Gastroenterology 1 department of the IRCCS "Saverio de Bellis" will be enrolled. 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. 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.

You may qualify if:

• 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

You may not qualify if:

• Patients treated with Warfarin, an anticoagulant, as it can increase DCP levels in the absence of HCC, risking giving false positives

Sponsors & Collaborators

• Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis: lead
• Dr. Raffaele Cozzolongo: collaborator
• Dr. Palma Aurelia Iacovazzi: collaborator
• Dr. Vito Giannuzzi: collaborator
• Dr. Francesco Losito: collaborator
• Dr. Marianna Zappimbulso: collaborator

Study Sites (1)

RCCS "Saverio de Bellis"

Castellana Grotte, Bari, 70013, Italy

RECRUITING

Related Publications (4)

• European Association for the Study of the Liver. EASL Clinical Practice Guidelines: Management of hepatocellular carcinoma. J Hepatol. 2018 Jul;69(1):182-236. doi: 10.1016/j.jhep.2018.03.019. Epub 2018 Apr 5. No abstract available.

  PMID: 29628281 BACKGROUND

• Demirtas CO, Brunetto MR. Surveillance for hepatocellular carcinoma in chronic viral hepatitis: Is it time to personalize it? World J Gastroenterol. 2021 Sep 7;27(33):5536-5554. doi: 10.3748/wjg.v27.i33.5536.

  PMID: 34588750 BACKGROUND

• Stefaniuk P, Cianciara J, Wiercinska-Drapalo A. Present and future possibilities for early diagnosis of hepatocellular carcinoma. World J Gastroenterol. 2010 Jan 28;16(4):418-24. doi: 10.3748/wjg.v16.i4.418.

  PMID: 20101765 BACKGROUND

• Yang JD, Addissie BD, Mara KC, Harmsen WS, Dai J, Zhang N, Wongjarupong N, Ali HM, Ali HA, Hassan FA, Lavu S, Cvinar JL, Giama NH, Moser CD, Miyabe K, Allotey LK, Algeciras-Schimnich A, Theobald JP, Ward MM, Nguyen MH, Befeler AS, Reddy KR, Schwartz M, Harnois DM, Yamada H, Srivastava S, Rinaudo JA, Gores GJ, Feng Z, Marrero JA, Roberts LR. GALAD Score for Hepatocellular Carcinoma Detection in Comparison with Liver Ultrasound and Proposal of GALADUS Score. Cancer Epidemiol Biomarkers Prev. 2019 Mar;28(3):531-538. doi: 10.1158/1055-9965.EPI-18-0281. Epub 2018 Nov 21.

  PMID: 30464023 BACKGROUND

Related Links

• 10 Asks to Improve Liver Cancer Care in Europe

MeSH Terms

Conditions

Liver Cirrhosis; Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fatty Liver

Study Officials

• Endrit Shahini, MD

  IRCCS "Saverio de Bellis" - Castellana Grotte (BA) - Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Endrit Shahini, MD

CONTACT

00390804994249; endrit.shahini@irccsdebellis.it

Raffaele Cozzolongo, MD

CONTACT

00390804994249; raffaele.cozzolongo@irccsdebellis.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 15, 2023
• First Posted: March 23, 2023
• Study Start: February 24, 2023
• Primary Completion: June 27, 2024
• Study Completion: January 27, 2025
• Last Updated: April 8, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)