RecruitingNCT07310693

External Validation of the CLOVER Score for Detecting Occult Cancer in Venous Thromboembolism Patients

External Validation of a Predictive Model for Occult Cancer Risk in Patients With Venous Thromboembolism Developed Using Machine Learning


Sponsor

Infanta Leonor University Hospital

Enrollment

500 participants

Start Date

Dec 1, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

This study aims to externally validate the CLOVER score, a machine learning-based predictive model designed to identify patients with venous thromboembolism (VTE) who are at increased risk of having an occult cancer. The study includes a retrospective cohort of patients with acute symptomatic VTE diagnosed between 2000 and 2022, and a prospective cohort of consecutively recruited patients from December 2025 to December 2027. The CLOVER model will be applied to all participants, and its ability to discriminate between patients with and without occult cancer will be evaluated. The study also assesses clinicians' satisfaction with the web-based tool (CLOVER-Web) developed to facilitate the use of the score in clinical practice.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • Age ≥18 years.
  • Objectively confirmed acute symptomatic venous thromboembolism (deep vein thrombosis and/or pulmonary embolism).
  • Ability to provide written or electronic informed consent.

Exclusion Criteria3

  • Suspicion of cancer during the initial diagnostic evaluation for VTE.
  • Participation in another interventional study that may interfere with outcomes.
  • Inability or refusal to provide informed consent.

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Locations(12)

Hospital Clínic

Barcelona, Barcelona, Spain

Hospital Universitario Infanta Leonor

Madrid, Madrid, Spain

Hospital Universitario La Paz

Madrid, Madrid, Spain

Hospital Universitario Príncipe de Asturias

Madrid, Madrid, Spain

Hospital Universitatio del Sureste

Madrid, Madrid, Spain

Hospital Universitario de Móstoles

Madrid, Madrid, Spain

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, Murcia, Spain

Hospital Universitario Morales Meseguer

Murcia, Murcia, Spain

Hospital San Agustín

Avilés, Principality of Asturias, Spain

Hospital Universitario Son Llatzer

Balea, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario de Fuenlabrada

Madrid, Spain

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NCT07310693


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