Intensive Cancer Screening After Cryptogenic Stroke (INCOGNITO) Pilot Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Participant Recruitment
研究概览
简要总结
The INCOGNITO Pilot Trial is a single centre pilot prospective randomized open-label blinded endpoint (PROBE) trial to assess the feasibility of a full-scale randomized trial to determine whether an occult cancer screening strategy of FDG PET/CT (F-fluorodeoxyglucose positron emission/computed tomography) in addition to usual care increases the number of occult cancers diagnosed after screening compared to usual care cancer screening alone in patients with cryptogenic stroke.
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
- Single (Outcomes Assessor)
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
- •adults ≥18 years
- •presenting to the Ottawa Hospital Stroke Prevention Clinic or the Ottawa Hospital Neurovascular Unit with a first cryptogenic ischemic stroke after advanced evaluation as per American Heart Association guidelines and Saver approach (maximum 3 months after stroke)
- •patient or delegate willing and able to provide informed consent.
排除标准
- •contraindications to FDG PET/CT (pregnancy or unable to lie still in bed for 20 minutes)
- •active cancer or previous cancer diagnosis (other than basal or squamous cell carcinoma of the skin)
研究组 & 干预措施
Intensive Cancer Screening
Usual care plus FDG PET/CT
干预措施: FDG PET/CT (Diagnostic Test)
Usual Care
Cancer screening according to sex, age and risk as per Canadian Task Force on Preventative Health Care)
干预措施: Usual Care (Diagnostic Test)
结局指标
主要结局
Participant Recruitment
时间窗: Over 12 months
Number of participants recruited
次要结局
- Eligibility Rate(Over 12 months)
- Consent Rate(Over 12 months)
- Retention Rate(Over 24 months)
- Study Completion Rate(Over 24 months)
- Adherence Rate(Over 24 months)
- Study Completion Rate(Over 24 months)
- Consent Rate(Over 12 months)
- Eligibility Rate(Over 12 months)
- Retention Rate(Over 24 months)
- Adherence Rate(Over 24 months)