Platelet RNA Profiling to Detect Occult Cancer in Patients With Unprovoked Venous Thromboembolism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 476
- 试验地点
- 14
- 主要终点
- Any solid or hematological cancer
研究概览
简要总结
Among patients with a first episode of unprovoked venous thromboembolism (VTE), the contemporary one-year risk of detecting occult cancer is approximately 4% to 7%. Of these cases, 30% to 60% are missed by routine limited screening for cancer. RNA profiling of platelets is a promising, highly accurate biomarker for cancer detection, but its clinical utility in patients with unprovoked VTE is unknown. The objective of the present study is to evaluate the diagnostic accuracy of platelet RNA profiling in detecting occult cancer in patients with unprovoked venous thromboembolism. Secondary objectives include evaluation of other biomarkers for cancer, prediction of bleeding, and prediction of recurrent VTE.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First episode of objectively confirmed, symptomatic, unprovoked symptomatic pulmonary embolism and/or distal or proximal deep vein thrombosis of the leg
- •Age 40 years or older
- •Written informed consent
排除标准
- •known malignant disease prior to VTE defined as a cancer diagnosis or cancer treatment within the past 5 years (of note: suspected but unconfirmed cancer at diagnosis of VTE is allowed);
- •trauma or fracture of the leg, surgical procedures, general anesthesia, or immobilization greater than 3 days within previous 3 months;
- •previous unprovoked venous thromboembolism;
- •known hereditary or acquired thrombophilia;
- •current pregnancy or puerperium (up to 3 months postpartum);
- •current estrogen therapy.
- •Greater than 10 days after VTE diagnosis;
- •Inability for blood withdrawal at baseline;
- •Inability or refusal to provide written informed consent.
结局指标
主要结局
Any solid or hematological cancer
时间窗: Up to one year following venous thromboembolism
Adjudicated diagnosis of solid or haematological cancer which is confirmed by histology or cytology, or is unequivocally diagnosed by either imaging or tumour markers
次要结局
- Cancer-related mortality(Up to one year following venous thromboembolism)
- Early-stage solid cancer(Up to one year following venous thromboembolism)
- Major bleeding(Up to one year following venous thromboembolism)
- Composite of solid cancer and lymphoma(Up to one year following venous thromboembolism)
- Recurrent venous thromboembolism(Up to one year following venous thromboembolism)
- Composite of major bleeding and clinically relevant non-major bleeding(Up to one year following venous thromboembolism)
- Solid cancer(Up to one year following venous thromboembolism)
- Clinically relevant non-major bleeding(Up to one year following venous thromboembolism)
- All-cause mortality(Up to one year following venous thromboembolism)
- Hematological cancer(Up to one year following venous thromboembolism)
研究者
Harry R. Buller
Professor of Vascular Medicine
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)