CLOVER score to find hidden cancer in people with venous blood clots
External Validation of a Predictive Model for Occult Cancer Risk in Patients With Venous Thromboembolism Developed Using Machine Learning
This project will test whether the CLOVER score can help find undiagnosed cancer in adults who have had a symptomatic venous blood clot.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Infanta Leonor University Hospital Academic / other |
| Locations | 12 sites (Barcelona, Barcelona and 11 other locations) |
| Trial ID | NCT07310693 on ClinicalTrials.gov |
What this trial studies
The study applies the machine-learning CLOVER score to two cohorts: a retrospective group of adults with objectively confirmed deep vein thrombosis or pulmonary embolism from 2000–2022 and a prospective group enrolled from December 2025 to December 2027. Patients from the centers that developed the model are excluded from the retrospective cohort, and required clinical and laboratory variables are extracted from electronic health records using a standardized form. The CLOVER-Web tool will be used to calculate each patient’s risk and the model’s discrimination for occult cancer will be measured. Clinician satisfaction with the web-based implementation will also be recorded to gauge usability in routine practice.
Who should consider this trial
Good fit: Adults (≥18 years) with objectively confirmed acute symptomatic deep vein thrombosis and/or pulmonary embolism who can provide informed consent and do not have suspected cancer at presentation.
Not a fit: Patients who already have suspicion of cancer at the time of VTE diagnosis, who cannot or refuse to give consent, or who are enrolled in conflicting interventional studies are unlikely to benefit from this validation effort.
Why it matters
Potential benefit: If successful, the score could help clinicians focus cancer screening on VTE patients at higher risk, potentially enabling earlier cancer diagnosis.
How similar studies have performed: Other predictive models and the original CLOVER derivation showed promising performance, but external validation of CLOVER across independent hospital cohorts is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Barcelona, Barcelona and 11 other locations
- Hospital Clínic — Barcelona, Barcelona, Spain (Recruiting)
- Hospital Universitario Infanta Leonor — Madrid, Madrid, Spain (Recruiting)
- Hospital Universitario La Paz — Madrid, Madrid, Spain (Recruiting)
- Hospital Universitario Príncipe de Asturias — Madrid, Madrid, Spain (Recruiting)
- Hospital Universitatio del Sureste — Madrid, Madrid, Spain (Recruiting)
- Hospital Universitario de Móstoles — Madrid, Madrid, Spain (Recruiting)
- Hospital Clínico Universitario Virgen de la Arrixaca — Murcia, Murcia, Spain (Recruiting)
- Hospital Universitario Morales Meseguer — Murcia, Murcia, Spain (Recruiting)
- Hospital San Agustín — Avilés, Principality of Asturias, Spain (Recruiting)
- Hospital Universitario Son Llatzer — Balea, Spain (Recruiting)
- Hospital Universitario 12 de Octubre — Madrid, Spain (Recruiting)
- Hospital Universitario de Fuenlabrada — Madrid, Spain (Recruiting)
Study contacts
- Principal investigator: Anabel Franco-Moreno, MD, PhD — Hospital Universitario Infanta Leonor
- Study coordinator: Anabel Franco Moreno, MD, PhD
- Email: afranco278@hotmail.com
- Phone: +34686102661
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.