| Title: |
Surveillance and treatment of primary hepatocellular carcinoma (aka. STOP HCC): protocol for a prospective cohort study of high-risk patients for HCC using GALAD-score |
| Authors: |
Truong, TN; Pham, TND; Hoang, LB; Nguyen, VT; Dao, HV; Dao, DVB; Alessy, S; Pham, HB; Pham, TTT; Nguyen, LDD; Nguyen, K; Abaalkhail, F; Manal, M; Mawardi, M; AlZahrani, M; Alswat, K; Alghamdi, H; Sanai, FM; Siddiqui, MA; Nguyen, NH; Vaidya, D; Phan, HT; Johnson, PJ; Alqahtani, SA; Dao, DY |
| Publisher Information: |
Springer Science and Business Media LLC |
| Publication Year: |
2023 |
| Collection: |
The University of Liverpool Repository |
| Description: |
Background: Vietnam and Saudi Arabia have high disease burden of primary hepatocellular carcinoma (HCC). Early detection in asymptomatic patients at risk for HCC is a strategy to improve survival outcomes in HCC management. GALAD score, a serum-based panel, has demonstrated promising clinical utility in HCC management. However, in order to ascertain its potential role in the surveillance of the early detection of HCC, GALAD needs to be validated prospectively for clinical surveillance of HCC (i.e., phase IV biomarker validation study). Thus, we propose to conduct a phase IV biomarker validation study to prospectively survey a cohort of patients with advanced fibrosis or compensated cirrhosis, irrespective of etiologies, using semi-annual abdominal ultrasound and GALAD score for five years. Methods: We plan to recruit a cohort of 1,600 patients, male or female, with advanced fibrosis or cirrhosis (i.e., F3 or F4) and MELD ≤ 15, in Vietnam and Saudi Arabia (n = 800 each). Individuals with a liver mass ≥ 1 cm in diameter, elevated alpha-fetoprotein (AFP) (≥ 9 ng/mL), and/or elevated GALAD score (≥ -0.63) will be scanned with dynamic contrast-enhanced magnetic resonance imaging (MRI), and a diagnosis of HCC will be made by Liver Imaging Reporting and Data System (LiRADS) assessment (LiRADS-5). Additionally, those who do not exhibit abnormal imaging findings, elevated AFP titer, and/or elevated GALAD score will obtain a dynamic contrast-enhanced MRI annually for five years to assess for HCC. Only MRI nearest to the time of GALAD score measurement, ultrasound and/or AFP evaluation will be included in the diagnostic validation analysis. MRI will be replaced with an abdominal computed tomography scan when MRI results are poor due to patient conditions such as movement etc. Gadolinium-ethoxybenzyl-diethylenetriamine pentaacetic acid-enhanced MRI will not be carried out in study sites in both countries. Bootstrap resampling technique will be used to account for repeated measures to estimate standard errors and confidence ... |
| Document Type: |
article in journal/newspaper |
| File Description: |
application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| Language: |
English |
| ISSN: |
1471-2407 |
| Relation: |
https://livrepository.liverpool.ac.uk/3172938/1/STOP-HCC_Protocol_BMC-Cancer%28SubmittedVersion%29.docx; Collapse authors list. Truong, TN, Pham, TND, Hoang, LB, Nguyen, VT, Dao, HV, Dao, DVB, Alessy, S, Pham, HB, Pham, TTT, Nguyen, LDD et al (show 15 more authors) , Nguyen, K, Abaalkhail, F, Manal, M, Mawardi, M, AlZahrani, M, Alswat, K, Alghamdi, H, Sanai, FM, Siddiqui, MA, Nguyen, NH, Vaidya, D, Phan, HT, Johnson, PJ orcid:0000-0003-1404-0209 , Alqahtani, SA orcid:0000-0003-2017-3526 and Dao, DY (2023) Surveillance and treatment of primary hepatocellular carcinoma (aka. STOP HCC): protocol for a prospective cohort study of high-risk patients for HCC using GALAD-score BMC Cancer, 23 (1). 875-. ISSN 1471-2407, 1471-2407 |
| DOI: |
10.1186/s12885-023-11167-9 |
| Availability: |
https://livrepository.liverpool.ac.uk/3172938/; https://doi.org/10.1186/s12885-023-11167-9 |
| Accession Number: |
edsbas.A4EA973B |
| Database: |
BASE |