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Completed

NCT Number: NCT02623712

The Watch the Spot Trial

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.

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Key information

Conditions

Solitary Pulmonary Nodule Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Coin Lesion, Pulmonary Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente Southern California

Pasadena, California, 91011, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

More Frequent Surveillance Strategy

Other

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)

Less Frequent Surveillance Strategy

Other

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 outcomes

  1. 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.

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

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

Registry information

Official study title

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

Acronym: WTS

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Dec 8, 2015
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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