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临床试验/NCT05733416
NCT05733416招募中不适用

Intensive Cancer Screening After Cryptogenic Stroke (INCOGNITO) Pilot Randomized Trial

Ottawa Hospital Research Institute2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2023年9月1日最近更新:
适应症

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

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)

结局指标

主要结局

Participant Recruitment

时间窗: Over 12 months

Number of participants recruited

次要结局

  • 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)
  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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