External Validation of the CLOVER Score for Detecting Occult Cancer in Venous Thromboembolism Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInfanta Leonor University Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years.
Objectively confirmed acute symptomatic venous thromboembolism (deep vein thrombosis and/or pulmonary embolism).
Ability to provide written or electronic informed consent.
Disqualifiers
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.
Trial population
Adults (≥18 years) with objectively confirmed symptomatic venous thromboembolism (deep vein thrombosis or pulmonary embolism) who are consecutively recruited in participating hospitals in Spain. All participants undergo routine clinical evaluation, laboratory testing, and age- and sex-appropriate cancer screening according to standard practice. The population represents real-world patients with new-onset VTE without known or suspected cancer at baseline.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
500 Participants
are grouped into 1 trial groupGroup A: Prospective VTE Cohort
Trial outcomes
Primary outcomes
1
Detection of occult cancer within 24 months
Proportion of participants with a histologically confirmed diagnosis of occult cancer identified between 1 and 24 months after the index venous thromboembolism (VTE) event. Occult cancer is defined as a new cancer diagnosis not clinically evident at the time of VTE diagnosis
Time frame
24 monthsSponsors and contacts
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Infanta Leonor University Hospital
Lead sponsor
Fundación para la Investigación e Innovación Biomédica del Hospital Universitario Infanta Leonor
Collaborator
Source ClinicalTrials.gov