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Brief Title: Screening for Cancer in Patients With Unprovoked VTE
Official Title: PET / CT Scan to Detect Cancer in Patients With Unprovoked Venous Thromboembolic Disease. Open Randomized Clinical Trial.
Study ID: NCT03937583
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain
Fundació Hospital de L'Esperit Sant, Santa Coloma De Gramenet, Barcelona, Spain
Hospital Universitario Virgen del Rocío, Sevilla, Seville, Spain
Hospital Clínic de Barcelona, Barcelona, , Spain
Hospital del Mar, Barcelona, , Spain
Hospital Vall d'Hebrón, Barcelona, , Spain
Consorcio Hospitalario Provincial de Castellón, Castelló, , Spain
Hospital Universitario Reina Sofía, Córdoba, , Spain
Hospital de Granollers, Granollers, , Spain
Clínica Universidad de Navarra, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario Infanta Sofía, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Hospital Universitario Virgen de la Arrixaca, Murcia, , Spain
Clínica Universidad de Navarra, Pamplona, , Spain
Hospital Universitario de Valme, Sevilla, , Spain
Hospital Universitari i Politècnic La Fe, Valencia, , Spain
Name: Luis Jara Palomares, MD/PhD
Affiliation: Hospitales Universitarios Virgen del Rocío
Role: PRINCIPAL_INVESTIGATOR