Occult cancer in patients with unprovoked venous thromboembolism: Rationale, design, and methods of the VaLRIETEs study and the SOME-RIETE trial - 08/03/25

Doi : 10.1016/j.ahj.2025.02.004

Maria Barca-Hernando, MD, PhD ^a, Sonia Otalora-Valderrama, MD, PhD ^b, Juan Jose Lopez-Nuñez, MD, PhD ^c,^d, Jose Portillo-Sanchez, MD, PhD ^e, Javier Pagan-Escribano, MD, PhD ^f, Patricia Lopez-Miguel, MD ^g, Isabelle Mahe, MD, PhD ^h,ⁱ, Elisabeth Mena-Muñoz, MD ^j, Ines Jou-Segovia, MD ^k, Egidio Imbalzano, MD ^l, Paloma Agudo-de Blas, MD, PhD ^m, Alicia Lorenzo-Hernandez, MD, PhD ⁿ, Carmen Diaz-Pedroche, MD, PhD ^m, Jesus Aibar-Gallizo, MD, PhD ^o, Gloria de la Red-Bellvis, MD ^p, Fatima del Molino-Sanz, MD ^q, Cristina Amado-Fernandez, MD ^r, Jose Luis Fernandez-Reyes, MD ^s, Aurora Villalobos-Sanchez, MD, PhD ^t, Juan Bosco Lopez-Saez, MD, PhD ^u, Ana Maria Diaz-Brasero, MD ^v, Maria Marcos-Jubilar, MD, PhD ^w, Jose Meireles, MD ^x, Pablo Javier Marchena-Yglesias, MD ^y, Jose Antonio Diaz-Peromingo, MD ^z, Samira Marin-Romero, MD, PhD ^a, Teresa Elias-Hernandez, MD, PhD ^a, Henry A Andrade-Ruiz, MD, PhD ^aa, Ghazaleh Mehdipour, MD ^bb, Behnood Bikdeli, MD, MS ^cc,^dd, Luis Jara-Palomares, MD, PhD ^a,^d,^ee,^⁎
The SOME-RIETE and ValRIETEs Investigators^⁎
A full list of SOME-RIETE and ValRIETEs investigators is given in the APPENDIX.
^a Respiratory Unit, Virgen del Rocio University Hospital, Seville, Spain
^b Department of Internal Medicine, Hospital Clínico Universitario Virgen de la Arrixaca, Murcia, Spain
^c Department of Internal Medicine, Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain
^d CIBERES, Carlos III Health Institute, Madrid, Spain
^e Department of Internal Medicine, Hospital General Universitario de Ciudad Real, Ciudad Real, Spain
^f Department of Internal Medicine, Hospital General Universitario Morales Meseguer, Murcia, Spain
^g Department of Pneumonology, Hospital General Universitario de Albacete, Albacete, Spain
^h Department of Internal Medicine, Hôpital Louis Mourier, AP-HP, Colombes, France
ⁱ Paris Cité University, UMR_S1140 Innovations Therapeutiques en Hémostase, Paris, France,
^j Department of Internal Medicine, Hospital Universitario Vall d'Hebron, Barcelona, Spain
^k Department of Internal Medicine, Hospital Universitari de Girona Doctor Josep Trueta, Gerona, Spain
^l Department of Clinical and Experimental Medicine, A.O.U Policlinico “G. Martino”, Messina, Italy
^m Department of Internal Medicine, Hospital Universitario 12 de Octubre, Madrid, Spain
ⁿ Department of Internal Medicine, Hospital Universitario La Paz, Madrid, Spain
^o Internal Medicine Department, Hospital Clínic de Barcelona, Instituto de Investigaciones Biomédicas August Pi i Sunyer, University of Barcelona, Barcelona, Spain
^p Department of Internal Medicine, Fundació Hospital de L'Esperit Sant, Santa Coloma de Gramenet, Barcelona, Spain
^q Department of Internal Medicine, Hospital General de Granollers, Granollers, Barcelona, Spain
^r Department of Internal Medicine, Hospital Sierrallana, Torrelavega, Cantabria, Spain
^s Department of Internal Medicine, Hospital Universitario de Jaén, Jaén, Spain
^t Department of Internal Medicine, Hospital Universitario Regional de Málaga, Málaga, Spain
^u Department of Internal Medicine, Hospital Universitario de Puerto Real, Vejer de la Frontera, Cádiz, Spain
^v Department of Internal Medicine, Hospital Universitario de Guadalajara, Guadalajara, Spain
^w Department of Haematology, Clínica Universidad de Navarra, Pamplona, Spain
^x Department of Internal Medicine, Unidade Local de Saúde Entre Douro e Vouga, Santa María da Feira, Portugal
^y Department of Internal Medicine, Parc Sanitari Sant Joan de Déu-Hospital General, Barcelona, Spain
^z Department of Internal Medicine, Hospital Clínico Universitario de Santiago, Santiago de Compostela, Spain
^aa Methodological and Statistical Management Unit, Foundation for Health Research Management, FISEVI, Seville, Spain
^bb Division of Nuclear Medicine and Molecular Imaging, Department of Radiology, Montefiore Medical Center, Bronx, NY
^cc Division of Cardiovascular Medicine and Thrombosis Research Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA
^dd Yale-New Haven Hospital/ Yale Center for Outcomes Research & Evaluation, New Haven, CT
^ee Biomedical Institute of Sevilla, Seville, Spain

^#Reprint requests: Luis Jara-Palomares, MD, PhD, Respiratory Department, Hospital Virgen del Rocio, CIBERES, Sevilla, 41013, Av. Manuel Siurot s/n, Spain.Respiratory Department, Hospital Virgen del RocioCIBERESAv. Manuel Siurot s/nSevilla41013Spain

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). inicio.iface (1687-N-22).

Trial Registration

SOME-RIETE: ClinicalTrials.gov (NCT03937583).

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Graphical abstract

Image, graphical abstract

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Plan

Background

Overview

VaLRIETEs study

Study design and objectives

Patient population and eligibility

Data elements and follow-up

Outcomes

Sample size calculation and statistical analysis

SOME-RIETE trial

Study design and objectives

Eligibility criteria

Intervention and treatment

Outcomes

Sample size calculation and statistical analysis

Implications and expected impact of Val-RIETE and SOME-RIETE

CRediT authorship contribution statement

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Vol 284

P. 81-93 - juin 2025 Retour au numéro

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Occult cancer in patients with unprovoked venous thromboembolism: Rationale, design, and methods of the VaLRIETEs study and the SOME-RIETE trial - 08/03/25

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Study Registration

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