Summary

Eligibility
for people ages 35 years and up (full criteria)
Location
at UC Davis UCSF
Dates
study started
completion around

Description

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.

Official Title

The Watch the Spot Trial: A Pragmatic Trial of More Versus Less Intensive Strategies for Active Surveillance of Patients With Small Pulmonary Nodules

Details

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.

Keywords

Solitary Pulmonary Nodule, Coin Lesion, Pulmonary, Lung Neoplasms, Carcinoma, Non-small-cell Lung, Non-Small-Cell Lung Carcinoma, Multiple Pulmonary Nodules, More Frequent Surveillance Strategy, Less Frequent Surveillance Strategy

Eligibility

You can join if…

Open to people ages 35 years and up

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.

You CAN'T join if...

  • Pregnant Women
  • Age <35 years
  • Known diagnosis of cancer (except non-melanoma skin cancer) within 5 years

Location

  • Kaiser Permanente Southern California
    Pasadena California 91011 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Kaiser Permanente
ID
NCT02623712
Study Type
Interventional
Participants
Expecting 35200 study participants
Last Updated