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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05781568
Other study ID # RC202214
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 24, 2023
Est. completion date January 27, 2025

Study information

Verified date April 2024
Source Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Contact Endrit Shahini, MD
Phone 00390804994249
Email endrit.shahini@irccsdebellis.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Description:

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Study Design


Intervention

Diagnostic Test:
Biomarker dosage
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.

Locations

Country Name City State
Italy RCCS "Saverio de Bellis" Castellana Grotte Bari

Sponsors (6)

Lead Sponsor Collaborator
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis Dr. Francesco Losito, Dr. Marianna Zappimbulso, Dr. Palma Aurelia Iacovazzi, Dr. Raffaele Cozzolongo, Dr. Vito Giannuzzi

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. — View Citation

European Association for the Study of the Liver. Electronic address: easloffice@easloffice.eu; 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. Erratum In: J Hepatol. 2019 Apr;70(4):817. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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