External Validation of the CLOVER Score for Detecting Occult Cancer in Venous Thromboembolism Patients
CLOVER
External Validation of a Predictive Model for Occult Cancer Risk in Patients With Venous Thromboembolism Developed Using Machine Learning
1 other identifier
observational
500
1 country
12
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2025
Typical duration for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2025
CompletedFirst Submitted
Initial submission to the registry
December 8, 2025
CompletedFirst Posted
Study publicly available on registry
December 30, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
December 30, 2025
December 1, 2025
3.1 years
December 8, 2025
December 20, 2025
Conditions
Keywords
Outcome Measures
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
24 months
Study Arms (1)
Prospective VTE Cohort
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).
Eligibility Criteria
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.
You may qualify if:
- Age ≥18 years.
- Objectively confirmed acute symptomatic venous thromboembolism (deep vein thrombosis and/or pulmonary embolism).
- Ability to provide written or electronic informed consent.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Hospital Clínic
Barcelona, Barcelona, Spain
Hospital Universitario Infanta Leonor
Madrid, Madrid, 28051, Spain
Hospital Universitario La Paz
Madrid, Madrid, 28051, Spain
Hospital Universitario Príncipe de Asturias
Madrid, Madrid, 28051, Spain
Hospital Universitatio del Sureste
Madrid, Madrid, 28051, 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
Related Publications (1)
Franco-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: 39859000BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anabel Franco-Moreno, MD, PhD
Hospital Universitario Infanta Leonor
- PRINCIPAL INVESTIGATOR
Franco-Moreno, MD, PhD
Hospital Universitario Infanta Leonor
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Specialist in Internal Medicine
Study Record Dates
First Submitted
December 8, 2025
First Posted
December 30, 2025
Study Start
December 1, 2025
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
December 30, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- IPD will be available beginning 12 months after the completion of the study and will remain accessible for a period of 5 years. Supporting documentation will be provided during the same availability window.
- Access Criteria
- IPD will be available to qualified researchers who submit a methodologically sound research proposal. All requests must be evaluated and approved by the principal investigators. Access will require signing a data use agreement ensuring confidentiality and appropriate use. Data will be shared through the secure HORUS-ML platform.
De-identified individual participant data (IPD) will be shared, including baseline characteristics, clinical variables, imaging results, and outcomes related to occult cancer detection. Data will be made available to qualified investigators upon reasonable request and after signing a data sharing agreement ensuring confidentiality and appropriate use. IPD will be available beginning 12 months after study completion and will remain accessible for 5 years. Access to IPD will be granted to qualified researchers with a methodologically sound research proposal. Requests must be submitted to the study's coordinating center and will be evaluated by the principal investigators. A data use agreement will be required before any data transfer. Data will be hosted on the HORUS-ML secure research platform (restricted access).