The Watch the Spot Trial (WTS)

April 18, 2024 updated by: Michael K Gould, MD, Kaiser Permanente

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

35200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Pasadena, California, United States, 91011
        • Kaiser Permanente Southern California

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: More Frequent CT Surveillance
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: 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)
Active Comparator: Less Frequent CT Surveillance
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of cancerous nodules with tumor (T) stage greater than T1a disease by the AJCC staging system, 7th edition
Time Frame: 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.
24 months after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of days from date of nodule identification to date of cancer diagnosis
Time Frame: Up to 2 years
Ongoing, final analysis in year 5
Up to 2 years
Survival time from date of cancer diagnosis until death or end of study
Time Frame: Up to 4 years
Ongoing, final analysis in year 5
Up to 4 years
Emotional distress, measured with the Impact of Events Scale
Time Frame: Measured at 2 months, 13 months, and 25 months following nodule identification
Compare patient-reported emotional distress
Measured at 2 months, 13 months, and 25 months following nodule identification
Anxiety, measured with the State Anxiety Inventory, 6-item
Time Frame: Measured at 2 months, 13 months, and 25 months following nodule identification
Compare patient-reported anxiety
Measured at 2 months, 13 months, and 25 months following nodule identification
General health status, measured with a single question
Time Frame: Measured at 2 months, 13 months, and 25 months following nodule identification
Compare patient-reported general health status
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
Time Frame: Measured from date of nodule identification until date of cancer diagnosis or completion of 24 months of follow-up
Compare resource utilization.
Measured from date of nodule identification until 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)
Time Frame: Measured from date of nodule identification to date of cancer diagnosis or completion of 24 months of follow-up
Compare effective radiation doses received.
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 the dose length product (DLP), measured in mGy*cm
Time Frame: Measured from date of nodule identification to date of cancer diagnosis or completion of 24 months of follow-up
Compare effective radiation doses received.
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
Time Frame: Measured from date of nodule identification to date of cancer diagnosis or completion of 24 months of follow-up
Compare adherence to the recommended protocols for CT surveillance, and adherence to use of low radiation dose techniques.
Measured from date of nodule identification to date of cancer diagnosis or completion of 24 months of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaiser Permanente

Collaborators

Patient-Centered Outcomes Research Institute
University of California, Davis
University of California, San Francisco

Investigators

  • Principal Investigator: Michael K Gould, MD, MS, Kaiser Permanente School of Medicin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2017

Primary Completion (Estimated)

July 31, 2024

Study Completion (Estimated)

July 31, 2024

Study Registration Dates

First Submitted

December 1, 2015

First Submitted That Met QC Criteria

December 3, 2015

First Posted (Estimated)

December 8, 2015

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1000001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We plan to share de-identified IPD for all study variables with other researchers on request as long as there is an acceptable justification

IPD Sharing Time Frame

De-identified IPD will be made available within 6-12 months following study completion, to allow time for the primary study team to complete manuscripts that report on each of the 4 study aims.

IPD Sharing Access Criteria

Interested researchers will be required to submit a formal request with justification and aims to the study Data Coordinating Center. Requests will be reviewed and approved by the study Executive Committee. Relevant data use or data transfer agreements will need to be completed.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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