The Watch the Spot Trial (WTS)

Kaiser Permanente

Status: Completed

Conditions: Lung Neoplasms; Solitary Pulmonary Nodule; Carcinoma, Non-small-cell Lung; Coin Lesion, Pulmonary

Treatments: Other: More Frequent Surveillance Strategy; Other: Less Frequent Surveillance Strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT02623712

1000001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34,686 patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34,686 participants in 2 patient groups

More Frequent CT Surveillance

Active Comparator group

Description:

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)

Treatment:

Other: More Frequent Surveillance Strategy

Less Frequent CT Surveillance

Active Comparator group

Description:

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.

Treatment:

Other: Less Frequent Surveillance Strategy