National Liver Cancer Screening Trial (TRACER) study protocol.

IF 5.6 2区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY
Hepatology Communications Pub Date : 2024-11-04 eCollection Date: 2024-11-01 DOI:10.1097/HC9.0000000000000565
Amit G Singal, Neehar D Parikh, Fasiha Kanwal, Jorge A Marrero, Sneha Deodhar, Stephanie Page-Lester, Camden Lopez, Ziding Feng, Nabihah Tayob
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引用次数: 0

Abstract

Background: Professional guidelines recommend HCC screening in at-risk patients using semi-annual ultrasound with or without alpha-fetoprotein (AFP); however, this strategy has limited effectiveness due to low adherence and sensitivity. Increasing data support the potential role of blood-based biomarker panels, which could improve both aspects. The biomarker panel GALAD, comprised of sex, age, and 3 blood biomarkers (AFP, AFP-L3, and des-carboxy prothrombin des-carboxy prothrombin), has shown high sensitivity and specificity in biomarker phase II (case-control) and phase III (retrospective cohort) validation studies. However, prospective validation in a large phase IV biomarker clinical utility trial is necessary before its adoption in practice.

Methods: The National Liver Cancer Screening Trial is an adaptive pragmatic randomized phase IV trial, which began enrollment in January 2024, comparing ultrasound-based versus biomarker-based screening in 5500 patients with chronic hepatitis B infection or cirrhosis from any etiology. Eligible patients are randomly assigned in a 1:1 ratio to semi-annual screening with ultrasound ± alpha-fetoprotein (arm A) or semi-annual screening with GALAD (arm B). Randomization is stratified by enrollment site, liver disease severity (per Child-Pugh class), liver disease etiology (viral, nonviral, and noncirrhotic HBV), and sex. Patients are being recruited from 15 sites (a mix of tertiary care academic referral centers, safety-net health systems, and large community health systems) over a 3-year period, and the primary endpoint, reduction in late-stage HCC, will be assessed at the end of year 5.5.

Discussion: The results of this trial will inform the best strategy for HCC screening and early-stage detection in patients with chronic liver diseases. If GALAD shows superiority, HCC screening would primarily shift from an ultrasound-based strategy to the adoption of the biomarker panel.

Trial registration: NCT06084234.

Trial status: The TRACER Study is actively enrolling.

全国肝癌筛查试验(TRACER)研究方案。
背景:专业指南建议对高危患者进行每半年一次的甲胎蛋白(AFP)或不含甲胎蛋白(AFP)的超声波筛查;然而,由于依从性和灵敏度较低,这一策略的效果有限。越来越多的数据支持基于血液的生物标记物面板的潜在作用,它可以改善这两个方面。由性别、年龄和 3 个血液生物标记物(甲胎蛋白、甲胎蛋白-L3 和去羧凝血酶原)组成的生物标记物面板 GALAD 在生物标记物 II 期(病例对照)和 III 期(回顾性队列)验证研究中显示出较高的灵敏度和特异性。然而,在实际应用之前,有必要在大型 IV 期生物标志物临床实用性试验中进行前瞻性验证:全国肝癌筛查试验是一项适应性务实随机IV期试验,于2024年1月开始招募5500名任何病因引起的慢性乙型肝炎感染或肝硬化患者,比较基于超声和基于生物标志物的筛查。符合条件的患者将按 1:1 的比例随机分配到每半年一次的超声波±甲胎蛋白筛查(A 组)或每半年一次的 GALAD 筛查(B 组)。随机分配按报名地点、肝病严重程度(按 Child-Pugh 分级)、肝病病因(病毒性、非病毒性和非肝硬化 HBV)和性别进行分层。患者将在 3 年内从 15 个地点(包括三级医疗学术转诊中心、安全网医疗系统和大型社区医疗系统)招募,主要终点(晚期 HCC 的减少)将在第 5 年年底进行评估:讨论:这项试验的结果将为慢性肝病患者的 HCC 筛查和早期检测提供最佳策略。如果GALAD显示出优越性,HCC筛查将主要从基于超声波的策略转向采用生物标记物面板:试验注册:NCT06084234:试验注册:NCT06084234.试验状态:TRACER 研究正在积极注册中。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Hepatology Communications
Hepatology Communications GASTROENTEROLOGY & HEPATOLOGY-
CiteScore
8.00
自引率
2.00%
发文量
248
审稿时长
8 weeks
期刊介绍: Hepatology Communications is a peer-reviewed, online-only, open access journal for fast dissemination of high quality basic, translational, and clinical research in hepatology. Hepatology Communications maintains high standard and rigorous peer review. Because of its open access nature, authors retain the copyright to their works, all articles are immediately available and free to read and share, and it is fully compliant with funder and institutional mandates. The journal is committed to fast publication and author satisfaction. ​
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