The Watch the Spot Trial

Carcinoma, Non-small-cell Lung Clinical Trial

— WTS  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02623712
• Other study ID #: 1000001
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 6, 2017
• Est. completion date: July 31, 2024

Study information

• Verified date: April 2024
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 35200
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-small-cell Lung
• Coin Lesion, Pulmonary
• Lung Neoplasms
• Multiple Pulmonary Nodules
• Solitary Pulmonary Nodule

Intervention

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)
• 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.

Locations

Country	Name	City	State
United States	Kaiser Permanente Southern California	Pasadena	California

Sponsors (4)

Lead Sponsor	Collaborator
Kaiser Permanente	Patient-Centered Outcomes Research Institute, University of California, Davis, University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of days from date of nodule identification to date of cancer diagnosis	Ongoing, final analysis in year 5	Up to 2 years
Secondary	Survival time from date of cancer diagnosis until death or end of study	Ongoing, final analysis in year 5	Up to 4 years
Secondary	Emotional distress, measured with the Impact of Events Scale	Compare patient-reported emotional distress	Measured at 2 months, 13 months, and 25 months following nodule identification
Secondary	Anxiety, measured with the State Anxiety Inventory, 6-item	Compare patient-reported anxiety	Measured at 2 months, 13 months, and 25 months following nodule identification
Secondary	General health status, measured with a single question	Compare patient-reported general health status	Measured at 2 months, 13 months, and 25 months following nodule identification
Secondary	Numbers of imaging tests, biopsy tests and surgical procedures, measured by review of electronic health records	Compare resource utilization.	Measured from date of nodule identification until date of cancer diagnosis or completion of 24 months of follow-up
Secondary	Exposure to ionizing radiation, using the computed tomography dose index (CTDIvol), measured in mGy (milliGray)	Compare effective radiation doses received.	Measured from date of nodule identification to date of cancer diagnosis or completion of 24 months of follow-up
Secondary	Exposure to ionizing radiation, using the the dose length product (DLP), measured in mGy*cm	Compare effective radiation doses received.	Measured from date of nodule identification to date of cancer diagnosis or completion of 24 months of follow-up
Secondary	Numbers of CT scans recommended by the assigned protocol that were not ordered by the ordering provider, and/or not completed by the patient	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