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The Watch the Spot Trial (WTS)

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ClinicalTrials.gov Identifier: NCT02623712
Recruitment Status : Enrolling by invitation
First Posted : December 8, 2015
Last Update Posted : August 9, 2018
Sponsor:
Collaborators:
Patient-Centered Outcomes Research Institute
University of California, Davis
University of California, San Francisco
Information provided by (Responsible Party):
Michael K Gould, MD, Kaiser Permanente

Brief 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.

Condition or disease Intervention/treatment Phase
Solitary Pulmonary Nodule Coin Lesion, Pulmonary Lung Neoplasms Carcinoma, Non-small-cell Lung Other: More Frequent Surveillance Strategy Other: Less Frequent Surveillance Strategy Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 39981 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : March 6, 2017
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rashes

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.




Primary Outcome Measures :
  1. Proportion of cancerous nodules with stage greater than T1a disease [ 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 stage T1a.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  7. 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.

  8. 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.

  9. 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.



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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02623712


Locations
United States, California
Kaiser Permanente Southern California
Pasadena, California, United States, 91011
Sponsors and Collaborators
Kaiser Permanente
Patient-Centered Outcomes Research Institute
University of California, Davis
University of California, San Francisco
Investigators
Principal Investigator: Michael K Gould, MD, MS Kaiser Permanente Southern Californ

Publications:

Responsible Party: Michael K Gould, MD, Director for Health Services Research and Implementation Science, Kaiser Permanente
ClinicalTrials.gov Identifier: NCT02623712     History of Changes
Other Study ID Numbers: 1000001
First Posted: December 8, 2015    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Multiple Pulmonary Nodules
Solitary Pulmonary Nodule
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Carcinoma, Bronchogenic
Respiratory Tract Diseases