Carcinoma, Non-small-cell Lung Clinical Trial
— WTSOfficial title:
The Watch the Spot Trial: A Pragmatic Trial of More Versus Less Intensive Strategies for Active Surveillance of Patients With Small Pulmonary Nodules
Verified date | April 2024 |
Source | Kaiser Permanente |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Kaiser Permanente Southern California | Pasadena | California |
Lead Sponsor | Collaborator |
---|---|
Kaiser Permanente | Patient-Centered Outcomes Research Institute, University of California, Davis, University of California, San Francisco |
United States,
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
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 |
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