Screening for Cancer in Patients With Unprovoked VTE

Phase 4

• Conditions: Venous Thromboembolic Disease; Respiratory Disease; Pulmonary Disease; Deep Venous Thrombosis; Pulmonary Embolism; Screening; Undefined
• Interventions: Drug: Fludeoxyglucose 18F

• Registration Number: NCT03937583
• Lead Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

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

Not available

Study Timeline

• Study First Submitted: 2019-04-30
• Study First Submitted QC: 2019-05-02
• Study First Posted: 2019-05-06
• Study Start: 2019-10-23
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-25
• Last Update Posted: 2021-12-09
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 650

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Extended screening	Fludeoxyglucose 18F	Limited screening plus positron emission tomography / computed tomography with 18 FDG (18FDG PET-CT).

Primary Outcome Measures

Name	Time	Method
Number of neoplasms diagnosed using extended screening	After 3 years of follow-up	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.

Secondary Outcome Measures

Name	Time	Method
Overall survival of patients with high-risk unprovoked thromboembolic disease performing limited/extended screening	Until the patient death or finalization of study after three years of follow-up	Estimate the impact of an active cancer search strategy using PET-CT in the overall survival in patients with high-risk unprovoked thromboembolic disease.
European Quality of Life-5 (EQ-5D scale validated in Spanish) of patients with high-risk unprovoked thromboembolic disease performing limited/extended screening	Baseline and after 90, 180 and 365 days of follow-up	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.
Number of neoplasms diagnosed in early phase using extended screening	After 3 years of follow-up	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.

Trial Locations

Locations (16)

Clínica Universidad de Navarra; 🇪🇸 Pamplona, Spain

Hospital Universitario de Valme; 🇪🇸 Sevilla, Spain

Hospital Universitario Virgen del Rocío; 🇪🇸 Sevilla, Seville, Spain

Hospital Vall d'Hebrón; 🇪🇸 Barcelona, Spain

Hospital Universitario Reina Sofía; 🇪🇸 Córdoba, Spain

Fundació Hospital de L'Esperit Sant; 🇪🇸 Santa Coloma De Gramenet, Barcelona, Spain

Hospital Universitario Infanta Sofía; 🇪🇸 Madrid, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Hospital Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain

Hospital del Mar; 🇪🇸 Barcelona, Spain

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain

Hospital Universitari i Politècnic La Fe; 🇪🇸 Valencia, Spain

Hospital de Granollers; 🇪🇸 Granollers, Spain

Hospital Universitario Virgen de la Arrixaca; 🇪🇸 Murcia, Spain

Hospital Clínic de Barcelona; 🇪🇸 Barcelona, Spain

Consorcio Hospitalario Provincial de Castellón; 🇪🇸 Castelló, Spain