2024-514703-34-00尚未招募3 期
Screening for occult malignancy using 18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography (FDG PET/CT) in patients with unprovoked venous thromboembolism
Centre Hospitalier Regional Et Universitaire De Brest10 个研究点 分布在 1 个国家目标入组 638 人开始时间: 2024年6月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 638
- 试验地点
- 10
- 主要终点
- Occult cancer “missed” by cancer screening defined as proven cancer diagnosed (either biopsy proven cancer or cancer diagnosis approved by adjudication committee in the absence of biopsy proven cancer) from the time of cancer screening completion to the end of the 1-year follow-up period, and not detected at the time of screening.
研究概览
简要总结
To determine whether adding a FDG-PET/CT to a limited screening strategy misses less cancer than a limited cancer screening strategy alone in patients aged 50 years or older with a first unprovoked VTE over a 1-year follow-up period.
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patients aged 50 years or older with a new diagnosis of first unprovoked proximal deep vein thrombosis (DVT) and/or pulmonary embolism (PE) ≤ 4 weeks as detailed below will be eligible to participate into the study.
- •No recent paralysis, paresis, or prolonged immobilization> 3 days for acute medical condition or plaster cast of the lower limbs in the last 3 months.
- •No major surgery (within the past 3 months) requiring general or regional anaesthesia
- •No biological or clinical thrombophilia
- •No active malignancy (known malignancy, progressive and/or treated during the last 5 years) except for adequately treated basal or squamous cell carcinoma. Patients whose state of health suggests the presence of cancer at the time of diagnosis of VTE cannot be included in the protocol.
排除标准
- •Hypersensitivity to 18F-FDG or any of the excipients according to the product monograph
- •Unavailable to follow-up
- •VTE while on anticoagulation (e.g apixaban, rivaroxaban, edoxaban, dabigatran, warfarin)
- •VTE provoked by a major inherited or acquired risk factor
- •Refusal or inability to provide informed consent
- •Life expectancy <12 months
- •Ongoing pregnancy
- •Vulnerable individuals (Persons deprived of their liberty by judicial or administrative decision; Persons under psychiatric care under duress; Persons admitted to a health or social institution for purposes other than research; Persons of full age subject to a legal protection measure; persons under protective custody)
结局指标
主要结局
Occult cancer “missed” by cancer screening defined as proven cancer diagnosed (either biopsy proven cancer or cancer diagnosis approved by adjudication committee in the absence of biopsy proven cancer) from the time of cancer screening completion to the end of the 1-year follow-up period, and not detected at the time of screening.
Occult cancer “missed” by cancer screening defined as proven cancer diagnosed (either biopsy proven cancer or cancer diagnosis approved by adjudication committee in the absence of biopsy proven cancer) from the time of cancer screening completion to the end of the 1-year follow-up period, and not detected at the time of screening.
次要结局
- 2) Early-stage (T1-2N0M0 as per the World Health Organization TNM classification system) and advanced-stage tumors at initial screening and during follow-up.
- 1) New cancer diagnosis after completion of the initial allocated screening strategy.
- 3) Cancer-related mortality during a 5-year follow-up period.
- 4) Diagnosis of cancer and costs from the viewpoint of the healthcare system over a one-year period in order to estimate the additional cost per additional cancer detected and the incremental cost utility ratio
- 5) Additional tests following each strategy and during follow-up.
- 6) The data of this study will be used to develop a decision aid to assist future patients in the decision of cancer screening
研究者
Clinical trial manager
Scientific
Centre Hospitalier Regional Et Universitaire De Brest
研究点 (10)
Loading locations...
相似试验
进行中（未招募）
1 期
Screening for occult malignancy using 18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography (FDG PET/CT) in patients with unprovoked venous thromboembolismThromboembolic event, CancerCTIS2024-514703-34-00Centre Hospitalier Regional Et Universitaire De Brest638
进行中（未招募）
不适用
Screening for Occult Malignancy in Patients With Unprovoked Venous ThromboembolismEmbolism and ThrombosisNCT04304651University Hospital, Brest1,276
进行中（未招募）
1 期
18F-fluoride PET for Early Non-invasive Assessment of Cortical Bone Formation - Non-invasive Assessment of Cortical Bone Formation - Version 1EUCTR2009-016523-61-GBKing’s College London30
已完成
不适用
18F-Fluorocholine (18F-FCho) to Distinguish Necrosis From Recurrence in Brain MetastasesBrain MetastasesNCT02037945Memorial Sloan Kettering Cancer Center19
尚未招募
不适用
Imaging tumor angiogenesis using 18F-Fluciclatide PET/CT in patients with colorectal and pancreatic cancerNL-OMON21459MC30