Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Occult Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Venous Thromboembolism (VTE) | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Prospective VTE Cohort
- description
- Adults with objectively confirmed symptomatic venous thromboembolism (deep vein thrombosis and/or pulmonary embolism) consecutively enrolled from December 2025 to December 2027 in participating hospitals. All participants will undergo routine clinical evaluation, laboratory testing, and cancer screening according to standard practice. The CLOVER score will be calculated at baseline using the web-based tool (CLOVER-Web).
Primary outcomes (1)
- measure
- Detection of occult cancer within 24 months
- timeFrame
- 24 months
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDFranco-Moreno A, Madronal-Cerezo E, de Ancos-Aracil CL, Farfan-Sedano AI, Munoz-Rivas N, Bascunana Morejon-Giron J, Ruiz-Giardin JM, Alvarez-Rodriguez F, Prada-Alonso J, Gala-Garcia Y, Casado-Suela MA, Bustamante-Fermosel A, Alfaro-Fernandez N, Torres-Macho J; CLOVER Research Group. Development of a Predictive Model of Occult Cancer After a Venous Thromboembolism Event Using Machine Learning: The CLOVER Study. Medicina (Kaunas). 2024 Dec 27;61(1):18. doi: 10.3390/medicina61010018. PMID 39859000