The Watch the Spot Trial
Status: | Enrolling by invitation |
---|---|
Conditions: | Lung Cancer, Lung Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 35 - Any |
Updated: | 8/11/2018 |
Start Date: | March 6, 2017 |
End Date: | July 31, 2020 |
The Watch the Spot Trial: A Pragmatic Trial of More Versus Less Intensive Strategies for Active Surveillance of Patients With Small Pulmonary Nodules
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.
individuals who are found to have a small pulmonary nodule on chest computed tomography (CT)
scans.
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.
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.
Inclusion Criteria:
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.
Exclusion Criteria:
- Pregnant Women
- Age <35 years
- Known diagnosis of cancer (except non-melanoma skin cancer) within 5 years
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