Clinical trial · Interventional
Screening for Cancer in Patients With Unprovoked VTE
PET / CT Scan to Detect Cancer in Patients With Unprovoked Venous Thromboembolic Disease. Open Randomized Clinical Trial.
- 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)
Open and multicenter randomized clinical trial (1:1) comparing limited screening with extended screening with the performance of Positron emission tomography-computed tomography (PET-CT) scan in the search for neoplasms in patients with unprovoked venous thromboembolic disease at high risk of developing cancer at follow-up. Introduction: Cancer screening in patients with unprovoked venous thromboembolic disease (VTE) is controversial. In the last years, a score has been developed that selects patients at high risk of developing cancer during follow-up. Objective: To estimate the impact of an active cancer search strategy using 18-fluordesoxiglucose (FDG) PET-CT in unprovoked VTE with high-risk to develop cancer. Specific Objectives: 1) Number of neoplasms diagnosed in the screening process: 2) number of neoplasms diagnosed at an early stage, 3) impact on survival of the strategy; and 4) impact on the quality of life. Cancer will be considered from 30 days up to 12 months after the diagnosis of VTE. Scope: 20 Spanish hospitals. Design: Open-label, multicentre Randomized clinical trial (1: 1) comparing the performance of PET-CT versus limited screening for cancer. Population: Patients older than 18 years with unprovoked VTE at high risk of presenting cancer at follow-up (≥3 points in the score of Jara-Palomares et al., Chest 2017). Follow-up: 12 months after VTE. Sample: The sample size calculated is 650 patients, to obtain a power of 80%, with a level of significance of 5%, and taking into account a 10% loss of follow-up.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Deep Venous Thrombosis | — | UNRESOLVED | — |
| Pulmonary Disease | — | UNRESOLVED | — |
| Pulmonary Embolism | — | UNRESOLVED | — |
| Respiratory Disease | — | UNRESOLVED | — |
| Screening | — | UNRESOLVED | — |
| Undefined | — | UNRESOLVED | — |
| Venous Thromboembolic Disease | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fludeoxyglucose 18F | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Limited screening
- description
- Complete clinical history, along with routine physical, analytical examination (creatinine, sodium, potassium, red series, white series, liver and calcium profile) and chest x-ray.
- type
- EXPERIMENTAL
- label
- Extended screening
- description
- Limited screening plus positron emission tomography / computed tomography with 18 FDG (18FDG PET-CT).
- interventionNames
- Drug: Fludeoxyglucose 18F
Primary outcomes (1)
- measure
- Number of neoplasms diagnosed using extended screening
- timeFrame
- After 3 years of follow-up
- description
- Estimate the impact of an active cancer search strategy using PET-CT in the number of neoplasms diagnosed in the screening process in patients with high-risk unprovoked thromboembolic disease.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Over 18 years. * Diagnosis of venous thromboembolic disease (proximal deep vein thrombosis of lower limbs, pulmonary embolism or both) unprovoked. * High risk classification according to previously published and validated scale * Signature of informed consent form Exclusion Criteria: * Impossibility to continue an adequate follow-up. * Contrast hypersensitivity used for PET / CT (fludeoxyglucose (18FDG)) or any of the excipients according to the characteristics of the product.
References
Publications (1)
- DERIVEDBarca-Hernando M, Otalora-Valderrama S, Lopez-Nunez JJ, Portillo-Sanchez J, Pagan-Escribano J, Lopez-Miguel P, Mahe I, Mena-Munoz E, Jou-Segovia I, Imbalzano E, Agudo-de Blas P, Lorenzo-Hernandez A, Diaz-Pedroche C, Aibar-Gallizo J, de la Red-Bellvis G, Del Molino-Sanz F, Amado-Fernandez C, Fernandez-Reyes JL, Villalobos-Sanchez A, Lopez-Saez JB, Diaz-Brasero AM, Marcos-Jubilar M, Meireles J, Marchena-Yglesias PJ, Diaz-Peromingo JA, Marin-Romero S, Elias-Hernandez T, Andrade-Ruiz HA, Mehdipour G, Bikdeli B, Jara-Palomares L; SOME-RIETE and ValRIETEs Investigators. Occult cancer in patients with unprovoked venous thromboembolism: Rationale, design, and methods of the VaLRIETEs study and the SOME-RIETE trial. Am Heart J. 2025 Jun;284:81-93. doi: 10.1016/j.ahj.2025.02.004. Epub 2025 Feb 17. PMID 39971173