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Screening for Cancer in Patients With Unprovoked VTE — SOME-RIETE  

Pulmonary Embolism Clinical Trial

Official title:
PET / CT Scan to Detect Cancer in Patients With Unprovoked Venous Thromboembolic Disease. Open Randomized Clinical Trial.

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03937583
Study type Interventional
Source Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Contact Luis Jara Palomares, MD/PhD
Phone +34 955012144
Email luisoneumo@hotmail.com
Status Recruiting
Phase Phase 4
Start date October 23, 2019
Completion date December 31, 2023
View Details
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