Occult cancer in patients with unprovoked venous thromboembolism: Rationale, design, and methods of the VaLRIETEs study and the SOME-RIETE trial

IF 3.7 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

American heart journal Pub Date : 2025-02-17 DOI:10.1016/j.ahj.2025.02.004

Maria Barca-Hernando MD, PhD , Sonia Otalora-Valderrama MD, PhD , Juan Jose Lopez-Nuñez MD, PhD , Jose Portillo-Sanchez MD, PhD , Javier Pagan-Escribano MD, PhD , Patricia Lopez-Miguel MD , Isabelle Mahe MD, PhD , Elisabeth Mena-Muñoz MD , Ines Jou-Segovia MD , Egidio Imbalzano MD , Paloma Agudo-de Blas MD, PhD , Alicia Lorenzo-Hernandez MD, PhD , Carmen Diaz-Pedroche MD, PhD , Jesus Aibar-Gallizo MD, PhD , Gloria de la Red-Bellvis MD , Fatima del Molino-Sanz MD , Cristina Amado-Fernandez MD , Jose Luis Fernandez-Reyes MD , Aurora Villalobos-Sanchez MD, PhD , Juan Bosco Lopez-Saez MD, PhD , Luis Jara-Palomares MD, PhD

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引用次数: 0

Abstract

Background

Unprovoked venous thromboembolism (VTE) is considered when no clear major provoking factor for VTE is identified. Although the 1-year risk of diagnosing new cancer in these patients can be as high as 5%, the benefits of extensive screening remain uncertain. It is possible that in a risk-enriched population of patients, screening yields benefit. Recently, the RIETE score, a composite score including sex, age, chronic pulmonary disease, anemia, platelet count and previous VTE, was found to improve risk prediction for identification of occult cancer in patients with unprovoked VTE. As for screening tests, whole body 18F-fluorodeoxyglucose Positron Emission/Computed Tomography (18F-FDG PET/CT) is a promising and sensitive tool for occult cancer screening.

Methods

This manuscript summarizes the rationale and design of 2 prospective studies in patients with unprovoked symptomatic VTE: (1) ValRIETE is an international, multicenter, prospective, adaptative, cohort study that plans to include 1,550 patients; the adaptive design permits a sample size increase depending on the results of the predefined interim analysis. This study will enable the external validation of the RIETE score, with several ancillary aims related to additional clinical and biomarker predictors. Recruitment began in December 2022. (2) SOME-RIETE is an open-label, randomized, multicenter clinical trial that plans to enroll 650 patients with a RIETE score ≥3 to compare limited screening with limited screening plus whole body 18F-FDG PET/CT. The primary outcome is cancer diagnosis within 3 months after VTE event. Secondary outcomes include cancer diagnosis and mortality at 12 months.

Conclusions

This study provides clinically meaningful data on and the utility of extended screening of cancer by 18F-FDG PET/CT.

Study Registration

VaLRIETE study: ethics committee of the Virgen del Rocio University Hospital, Sevilla (Spain). https://www.juntadeandalucia.es/salud/portaldeetica/xhtml/inicio/inicio.iface (1687-N-22).

Trial Registration

SOME-RIETE: ClinicalTrials.gov (NCT03937583).

Abstract Image

查看原文本刊更多论文

无因性静脉血栓栓塞患者的隐匿性癌症：valriete研究和SOME-RIETE试验的基本原理、设计和方法

理由：当没有明确的诱发静脉血栓栓塞的主要因素时，考虑非诱发性静脉血栓栓塞（VTE）。尽管这些患者在1年内诊断出新癌症的风险可高达5%，但广泛筛查的益处仍不确定。在高风险人群中，筛查可能会产生益处。最近，RIETE评分（包括性别、年龄、慢性肺部疾病、贫血、血小板计数和既往静脉血栓栓塞）被发现可以提高非诱发性静脉血栓栓塞患者隐匿性癌症的风险预测。在筛查试验方面，全身18f -氟脱氧葡萄糖正电子发射/计算机断层扫描（18F-FDG PET/CT）是一种有前景且敏感的隐匿性癌症筛查工具。设计：本文总结了两项针对无诱因症状性静脉血栓栓塞患者的前瞻性研究的基本原理和设计：1)ValRIETE是一项国际性、多中心、前瞻性、适应性、队列研究，计划纳入1550名患者；自适应设计允许样本量的增加取决于预定义的中期分析的结果。这项研究将使RIETE评分的外部验证成为可能，并有几个辅助目标与其他临床和生物标志物预测相关。招聘于2022年12月开始。2) SOME-RIETE是一项开放标签、随机、多中心临床试验，计划招募650名RIETE评分≥3的患者，比较有限筛查与有限筛查加全身18F-FDG PET/CT。主要终点是静脉血栓栓塞事件后3个月内的癌症诊断。次要结局包括12个月时的癌症诊断和死亡率。本研究为18F-FDG PET/CT扩展癌症筛查提供了有临床意义的数据和应用。试验注册：someriete: ClinicalTrials.gov （NCT03937583）研究注册：ValRIETE研究：西班牙塞维利亚圣母罗西奥大学医院伦理委员会。https://www.juntadeandalucia.es/salud/portaldeetica/xhtml/inicio/inicio.iface (1687 - n - 22)。

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来源期刊

American heart journal 医学-心血管系统

CiteScore

8.20

自引率

2.10%

发文量

214

审稿时长

38 days

期刊介绍： The American Heart Journal will consider for publication suitable articles on topics pertaining to the broad discipline of cardiovascular disease. Our goal is to provide the reader primary investigation, scholarly review, and opinion concerning the practice of cardiovascular medicine. We especially encourage submission of 3 types of reports that are not frequently seen in cardiovascular journals: negative clinical studies, reports on study designs, and studies involving the organization of medical care. The Journal does not accept individual case reports or original articles involving bench laboratory or animal research.