Development of a Predictive Model of Occult Cancer After a Venous Thromboembolism Event Using Machine Learning: The CLOVER Study.
Anabel Franco-Moreno, Elena Madroñal-Cerezo, Cristina Lucía de Ancos-Aracil...
https://pubmed.ncbi.nlm.nih.gov/39859000Actively Recruiting
Age: 18Years +
All Genders
ID07310693
External Validation of a Predictive Model for Occult Cancer Risk in Patients With Venous Thromboembolism Using Machine Learning
Led by Infanta Leonor University Hospital · Updated on 2025-12-30
500
Participants Needed
12
Research Sites
N/A
Total Duration
On this page
Sponsors
I
Infanta Leonor University Hospital
Lead Sponsor
F
Fundación para la Investigación e Innovación Biomédica del Hospital Universitario Infanta Leonor
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the CLOVER score, a machine learning-based tool designed to predict the risk of hidden (occult) cancer in patients with venous thromboembolism (VTE), which includes conditions like deep vein thrombosis and pulmonary embolism. The study combines past patient data from 2000 to 2022 and newly enrolled patients from December 2025 to December 2027 to validate how well the CLOVER score identifies those at increased cancer risk. It also assesses how satisfied clinicians are with the web-based CLOVER tool designed to support clinical use. The study includes two groups: a retrospective cohort of adult patients with confirmed symptomatic VTE diagnosed in hospitals across Spain, excluding those from centers involved in developing the model, and a prospective cohort recruited consecutively from December 2025 to December 2027. For the prospective group, all participants will receive routine clinical evaluations, laboratory tests, chest X-rays, and cancer screenings based on guidelines. The CLOVER score will be calculated at diagnosis using the web tool, which classifies patients as low or high cancer risk. Participants will be followed for at least two years to identify any cancer diagnosis. Participants will undergo standard exams, lab tests, and imaging as part of routine care. Researchers will collect data from electronic health records for the retrospective group and monitor cancer outcomes over two years for the prospective group. The study measures how accurately the CLOVER score predicts occult cancer by evaluating sensitivity, specificity, and predictive values. Clinicians will complete an online survey to report their satisfaction with the CLOVER-Web tool. All data will be handled securely, with informed consent obtained from prospective participants, and privacy maintained throughout the study.
CONDITIONS
Brief Title
External Validation of the CLOVER Score for Detecting Occult Cancer in Venous Thromboembolism Patients
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Objectively confirmed acute symptomatic venous thromboembolism (deep vein thrombosis and/or pulmonary embolism)
- Ability to provide written or electronic informed consent
You will not qualify if you...
- Suspicion of cancer during the initial diagnostic evaluation for venous thromboembolism
- Participation in another interventional study that may interfere with outcomes
- Inability or refusal to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - Up to 2 years
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Monitoring
Duration - At least 24 months
Participants who undergo routine care are observed with clinical evaluations, laboratory tests, and cancer screenings according to standard practice.
Visits as per routine clinical care and cancer screening schedules
Trial Site Locations
Total: 12 locations
1
Hospital Clínic
Barcelona, Barcelona, Spain
Actively Recruiting
2
Hospital Universitario Infanta Leonor
Madrid, Madrid, Spain, 28051
Actively Recruiting
3
Hospital Universitario La Paz
Madrid, Madrid, Spain, 28051
Actively Recruiting
4
Hospital Universitario Príncipe de Asturias
Madrid, Madrid, Spain, 28051
Actively Recruiting
5
Hospital Universitatio del Sureste
Madrid, Madrid, Spain, 28051
Actively Recruiting
6
Hospital Universitario de Móstoles
Madrid, Madrid, Spain
Actively Recruiting
7
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, Murcia, Spain
Actively Recruiting
8
Hospital Universitario Morales Meseguer
Murcia, Murcia, Spain
Actively Recruiting
9
Hospital San Agustín
Avilés, Principality of Asturias, Spain
Actively Recruiting
10
Hospital Universitario Son Llatzer
Balea, Spain
Actively Recruiting
11
Hospital Universitario 12 de Octubre
Madrid, Spain
Actively Recruiting
12
Hospital Universitario de Fuenlabrada
Madrid, Spain
Actively Recruiting
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Research Team
A
Anabel Franco Moreno, MD, PhD
A
Anabel Franco Moreno
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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