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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
650
The performance of the 18 FDG PET-CT will require fasting of at least 6 hours, and the glycemia will have to be lower than 126 mg / dL before the injection of 3-5 MBq / kg of 18FDG. Intravenous injection will follow a period of approximately 60 minutes in a quiet room. Computed tomography (CT) will be performed from the middle of the forehead to the feet with normal and shallow breathing using a low dose adjustment Iodinated contrast will not be administered intravenously.
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
RECRUITINGFundació Hospital de L'Esperit Sant
Santa Coloma de Gramenet, Barcelona, Spain
RECRUITINGHospital Universitario Virgen del Rocío
Seville, Seville, Spain
RECRUITINGHospital Clínic de Barcelona
Barcelona, Spain
RECRUITINGHospital del Mar
Barcelona, Spain
RECRUITINGHospital Vall d'Hebrón
Barcelona, Spain
ACTIVE_NOT_RECRUITINGConsorcio Hospitalario Provincial de Castellón
Castelló, Spain
ACTIVE_NOT_RECRUITINGHospital Universitario Reina Sofía
Córdoba, Spain
ACTIVE_NOT_RECRUITINGHospital de Granollers
Granollers, Spain
RECRUITINGClínica Universidad de Navarra
Madrid, Spain
ACTIVE_NOT_RECRUITING...and 7 more locations
Number of neoplasms diagnosed using extended screening
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.
Time frame: After 3 years of follow-up
Number of neoplasms diagnosed in early phase using extended screening
Estimate the impact of an active cancer search strategy using PET-CT in the number of neoplasms diagnosed in early phase in the screening process in patients with high-risk unprovoked thromboembolic disease.
Time frame: After 3 years of follow-up
Overall survival of patients with high-risk unprovoked thromboembolic disease performing limited/extended screening
Estimate the impact of an active cancer search strategy using PET-CT in the overall survival in patients with high-risk unprovoked thromboembolic disease.
Time frame: Until the patient death or finalization of study after three years of follow-up
European Quality of Life-5 (EQ-5D scale validated in Spanish) of patients with high-risk unprovoked thromboembolic disease performing limited/extended screening
Estimate the impact of an active cancer search strategy using PET-CT in the quality of life evaluated with the scale EQ-5D in patients with high-risk unprovoked thromboembolic disease. The EQ-5D consists of 2 parts - the "Descriptive System" and the "Visual Analogue scale". The DS comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The EQ VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'. This information can be used as a quantitative measure of health as judged by the individual respondents.
Time frame: Baseline and after 90, 180 and 365 days of follow-up
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