NCT05389774招募中不适用
DOLCE: Determining the Impact of Optellum's Lung Cancer Prediction (LCP) Artificial Intelligence Solution on Service Utilisation, Health Economics and Patient Outcomes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 10
- 主要终点
- Determine the potential effect of the LCP on discharge
研究概览
简要总结
This study is a multi-centre prospective observational cohort study recruiting patients with 5-30mm solid and part-solid pulmonary nodules that have been detected on CT chest scans performed as part of routine practice. The aim is to determine whether physician decision making with the AI-based LCP tool, generates clinical and health-economic benefits over the current standard of care of these patients.
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
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are eligible for the study if all of the following apply:
- •Are aged 35 years or above
- •Have baseline CT study with at least one incidentally detected solid or part-solid (must have a solid component >=80%) pulmonary nodule that:
- •is not fully calcified
- •Is 5-30mm inclusive in maximum axial diameter for the whole lesion measured using manual electronic callipers
- •Have baseline CT study that includes at least one series that meets all of the following (training for this will be provided):
- •Is of a type that meets VNC instructions for use
- •Comprises at least one full-inspiration breath-hold scans without a high degree of contrast media and does not exhibit quality issues (e.g., motion artefacts)
排除标准
- •Patients will be excluded from the study if any of the following apply:
- •Have received a diagnosis for cancer in the last 5 years
- •Have thoracic implants that impact the image appearance of the nodule
- •Have more than five reported pulmonary nodules of any size or type excluding fully calcified nodules (this criterion is used as a proxy due to the risk of being an infection or metastasis)
- •Have one or more additional nodules where any of the following applies:
- •Are already undergoing follow-up according to pulmonary nodule management standard care
- •Pure ground glass opacity (GGO) of >=5mm in maximum axial diameter for the whole lesion measured using manual electronic callipers
- •>30mm in maximum axial diameter for the whole lesion measured using manual electronic callipers
结局指标
主要结局
Determine the potential effect of the LCP on discharge
时间窗: up to 1 year.
Measured difference between standard care, LCP and LCP-guided care for: * Percentage of cancer patients discharged (straight after assessment of the baseline scan) * Percentage of benign-nodule patients discharged (straight after assessment of the baseline scan)
次要结局
- Determine the potential effect of the LCP on possible adherence to clinical guidelines.(up to 1 year.)
- Determine the potential effect of the hypothetical LCP-informed care versus standard care on patient outcomes.(up to 1 year.)
- Determine the potential effect of the LCP on overall clinical management, as well as scan and procedure utilization.(up to 1 year.)
- Determine the potential health-economic effect of the hypothetical LCP-informed care versus standard care(up to 1 year.)
研究者
研究点 (10)
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