Trials / Completed
CompletedNCT02623712
The Watch the Spot Trial
The Watch the Spot Trial: A Pragmatic Trial of More Versus Less Intensive Strategies for Active Surveillance of Patients With Small Pulmonary Nodules
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 34,686 (actual)
- Sponsor
- Kaiser Permanente · Academic / Other
- Sex
- All
- Age
- 35 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | More Frequent Surveillance Strategy | Chest CT scans to be repeated at 3, 6, 12 and/or 24 months, depending on patient risk factors and nodule size and attenuation (density) |
| OTHER | Less Frequent Surveillance Strategy | Chest CT scans to be repeated at 3, 6, 12 and/or 24 months, depending on patient risk factors and nodule size and attenuation (density). Overall, participants in the less frequent arm are expected to undergo 30% fewer surveillance imaging tests. |
Timeline
- Start date
- 2017-03-06
- Primary completion
- 2024-09-04
- Completion
- 2024-09-04
- First posted
- 2015-12-08
- Last updated
- 2025-08-14
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02623712. Inclusion in this directory is not an endorsement.