The Watch the Spot Trial: A Pragmatic Trial of More Versus Less Intensive Strategies for Active Surveillance of Patients With Small Pulmonary Nodules
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34,686
- 试验地点
- 2
- 主要终点
- Proportion of cancerous nodules with tumor (T) stage greater than T1a disease by the AJCC staging system, 7th edition
研究概览
简要总结
This study will compare two clinically accepted protocols for surveillance imaging in individuals who are found to have a small pulmonary nodule on chest computed tomography (CT) scans.
详细描述
The investigators will conduct an unblinded, prospective, pragmatic, cluster-randomized, comparative effectiveness trial of more intensive versus less intensive CT surveillance of patients found to have small pulmonary nodules in diverse health care settings. The goal of this pragmatic clinical trial is to identify the surveillance strategy that will maximize early diagnosis for individuals with cancerous nodules, while minimizing unnecessary surveillance of patients without cancer that can result in emotional stress, exposure to harmful ionizing radiation, and the discovery of incidental findings that may lead to unnecessary treatment.
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
- None
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
- •The target population includes adults with small lung nodules that may represent a new diagnosis of lung cancer, who typically would be managed by CT surveillance in usual clinical practice. Thus, we will enroll all patients:
- •aged ≥35 years
- •at least one nodule measuring ≤15 mm in average diameter on chest CT.
排除标准
- •Pregnant Women
- •Age <35 years
- •Known diagnosis of cancer (except non-melanoma skin cancer) within 5 years
结局指标
主要结局
Proportion of cancerous nodules with tumor (T) stage greater than T1a disease by the AJCC staging system, 7th edition
时间窗: 24 months after enrollment
Among individuals with small pulmonary nodules identified either incidentally or by screening, compare more versus less intensive surveillance to determine the number of cancerous nodules that progress beyond T stage T1a.
次要结局
- Emotional distress, measured with the Impact of Events Scale(Measured at 2 months, 13 months, and 25 months following nodule identification)
- Anxiety, measured with the State Anxiety Inventory, 6-item(Measured at 2 months, 13 months, and 25 months following nodule identification)
- General health status, measured with a single question(Measured at 2 months, 13 months, and 25 months following nodule identification)
- Numbers of imaging tests, biopsy tests and surgical procedures, measured by review of electronic health records(Measured from date of nodule identification until date of cancer diagnosis or completion of 24 months of follow-up)
- Number of days from date of nodule identification to date of cancer diagnosis(Up to 2 years)
- Survival time from date of cancer diagnosis until death or end of study(Up to 4 years)
- Exposure to ionizing radiation, using the the dose length product (DLP), measured in mGy*cm(Measured from date of nodule identification to date of cancer diagnosis or completion of 24 months of follow-up)
- Exposure to ionizing radiation, using the computed tomography dose index (CTDIvol), measured in mGy (milliGray)(Measured from date of nodule identification to date of cancer diagnosis or completion of 24 months of follow-up)
- Numbers of CT scans recommended by the assigned protocol that were not ordered by the ordering provider, and/or not completed by the patient(Measured from date of nodule identification to date of cancer diagnosis or completion of 24 months of follow-up)
研究者
Michael K Gould, MD
Professor
Kaiser Permanente