PET / CT Scan to Detect Cancer in Patients With Unprovoked Venous Thromboembolic Disease. Open Randomized Clinical Trial.
试验速览
- 阶段
- 4 期
- 入组人数
- 650
- 试验地点
- 16
- 主要终点
- Number of neoplasms diagnosed using extended screening
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Extended screening
Limited screening plus positron emission tomography / computed tomography with 18 FDG (18FDG PET-CT).
干预措施: Fludeoxyglucose 18F (Drug)
结局指标
主要结局
Number of neoplasms diagnosed using extended screening
时间窗: 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.
次要结局
- 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)
- 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)
- Number of neoplasms diagnosed in early phase using extended screening(After 3 years of follow-up)