The Watch the Spot Trial

NCT02623712 | Completed DMC

• 1 other identifier: 1000001
• Study Type: interventional
• Target: 34,686
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Proportion of cancerous nodules with tumor (T) stage greater than T1a disease by the AJCC staging system, 7th edition

  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 Outcomes (9)

• Number of days from date of nodule identification to date of cancer diagnosis

  Up to 2 years

• Survival time from date of cancer diagnosis until death or end of study

  Up to 4 years

• Emotional distress, measured with the Impact of Events Scale

  Measured at 2 months, 13 months, and 25 months following nodule identification

• Anxiety, measured with the State Anxiety Inventory, 6-item

  Measured at 2 months, 13 months, and 25 months following nodule identification

• General health status, measured with a single question

  Measured at 2 months, 13 months, and 25 months following nodule identification

Study Arms (2)

More Frequent CT Surveillance

ACTIVE COMPARATOR

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

Less Frequent CT Surveillance

ACTIVE COMPARATOR

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

Interventions

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)

More Frequent CT Surveillance

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.

Less Frequent CT Surveillance

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

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

Sponsors & Collaborators

• Kaiser Permanente: lead
• Patient-Centered Outcomes Research Institute: collaborator
• University of California, Davis: collaborator
• University of California, San Francisco: collaborator

Study Sites (1)

Kaiser Permanente Southern California

Pasadena, California, 91011, United States

Location

Related Publications (12)

• MacMahon H, Austin JH, Gamsu G, Herold CJ, Jett JR, Naidich DP, Patz EF Jr, Swensen SJ; Fleischner Society. Guidelines for management of small pulmonary nodules detected on CT scans: a statement from the Fleischner Society. Radiology. 2005 Nov;237(2):395-400. doi: 10.1148/radiol.2372041887.

  PMID: 16244247 BACKGROUND

• Naidich DP, Bankier AA, MacMahon H, Schaefer-Prokop CM, Pistolesi M, Goo JM, Macchiarini P, Crapo JD, Herold CJ, Austin JH, Travis WD. Recommendations for the management of subsolid pulmonary nodules detected at CT: a statement from the Fleischner Society. Radiology. 2013 Jan;266(1):304-17. doi: 10.1148/radiol.12120628. Epub 2012 Oct 15.

  PMID: 23070270 BACKGROUND

• Gould MK, Donington J, Lynch WR, Mazzone PJ, Midthun DE, Naidich DP, Wiener RS. Evaluation of individuals with pulmonary nodules: when is it lung cancer? Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013 May;143(5 Suppl):e93S-e120S. doi: 10.1378/chest.12-2351.

  PMID: 23649456 BACKGROUND

• Berrington de Gonzalez A, Mahesh M, Kim KP, Bhargavan M, Lewis R, Mettler F, Land C. Projected cancer risks from computed tomographic scans performed in the United States in 2007. Arch Intern Med. 2009 Dec 14;169(22):2071-7. doi: 10.1001/archinternmed.2009.440.

  PMID: 20008689 BACKGROUND

• Smith-Bindman R. Is computed tomography safe? N Engl J Med. 2010 Jul 1;363(1):1-4. doi: 10.1056/NEJMp1002530. Epub 2010 Jun 23. No abstract available.

  PMID: 20573919 BACKGROUND

• Smith-Bindman R, Miglioretti DL, Johnson E, Lee C, Feigelson HS, Flynn M, Greenlee RT, Kruger RL, Hornbrook MC, Roblin D, Solberg LI, Vanneman N, Weinmann S, Williams AE. Use of diagnostic imaging studies and associated radiation exposure for patients enrolled in large integrated health care systems, 1996-2010. JAMA. 2012 Jun 13;307(22):2400-9. doi: 10.1001/jama.2012.5960.

  PMID: 22692172 BACKGROUND

• Gould MK, Tang T, Liu IL, Lee J, Zheng C, Danforth KN, Kosco AE, Di Fiore JL, Suh DE. Recent Trends in the Identification of Incidental Pulmonary Nodules. Am J Respir Crit Care Med. 2015 Nov 15;192(10):1208-14. doi: 10.1164/rccm.201505-0990OC.

  PMID: 26214244 BACKGROUND

• Wiener RS, Gould MK, Slatore CG, Fincke BG, Schwartz LM, Woloshin S. Resource use and guideline concordance in evaluation of pulmonary nodules for cancer: too much and too little care. JAMA Intern Med. 2014 Jun;174(6):871-80. doi: 10.1001/jamainternmed.2014.561.

  PMID: 24710850 BACKGROUND

• Brenner DJ, Hall EJ. Computed tomography--an increasing source of radiation exposure. N Engl J Med. 2007 Nov 29;357(22):2277-84. doi: 10.1056/NEJMra072149. No abstract available.

  PMID: 18046031 BACKGROUND

• Ost D, Fein AM, Feinsilver SH. Clinical practice. The solitary pulmonary nodule. N Engl J Med. 2003 Jun 19;348(25):2535-42. doi: 10.1056/NEJMcp012290. No abstract available.

  PMID: 12815140 BACKGROUND

• Gould MK, de Bie E, Qi L, Creekmur B, Mazzone PJ, Mularski RA, Ritzwoller DP, Slatore CG, Vachani A, Walter EC, Wiener RS, Dyer DS, McEvoy CE, Kelly K, Smith-Bindman R, Miglioretti DL; Watch the Spot Investigators. Baseline Characteristics of Participants and Pulmonary Nodules in the Watch the Spot Trial: A Pragmatic Trial of Less versus More Intensive Strategies for Active Surveillance of Patients With Small Pulmonary Nodules. Clin Lung Cancer. 2025 Sep;26(6):e472-e482.e1. doi: 10.1016/j.cllc.2025.05.011. Epub 2025 May 24.

  PMID: 40518364 DERIVED

• Gould MK, Creekmur B, Qi L, Golden SE, Kaplan CP, Walter E, Mularski RA, Vaszar LT, Fennig K, Steiner J, de Bie E, Musigdilok VV, Altman DA, Dyer DS, Kelly K, Miglioretti DL, Wiener RS, Slatore CG, Smith-Bindman R. Emotional Distress, Anxiety, and General Health Status in Patients With Newly Identified Small Pulmonary Nodules: Results From the Watch the Spot Trial. Chest. 2023 Dec;164(6):1560-1571. doi: 10.1016/j.chest.2023.06.022. Epub 2023 Jun 24.

  PMID: 37356710 DERIVED

MeSH Terms

Conditions

Solitary Pulmonary Nodule; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Officials

• Michael K Gould, MD, MS

  Kaiser Permanente School of Medicin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 1, 2015
• First Posted: December 8, 2015
• Study Start: March 6, 2017
• Primary Completion: September 4, 2024
• Study Completion: September 4, 2024
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

US (1)