Clinical trial · Interventional
The Watch the Spot Trial
The Watch the Spot Trial: A Pragmatic Trial of More Versus Less Intensive Strategies for Active Surveillance of Patients With Small Pulmonary Nodules
NCT02623712CI-TRIAL-00093599WTScompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-small-cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Coin Lesion, Pulmonary | — | UNRESOLVED | — |
| Lung Neoplasms | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Solitary Pulmonary Nodule | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Less Frequent Surveillance Strategy | Other | — | UNRESOLVED |
| More Frequent Surveillance Strategy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- More Frequent CT Surveillance
- description
- 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)
- interventionNames
- Other: More Frequent Surveillance Strategy
- type
- ACTIVE_COMPARATOR
- label
- Less Frequent CT Surveillance
- description
- 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.
- interventionNames
- Other: Less Frequent Surveillance Strategy
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 35 Years
Show eligibility criteria text
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
References
Publications (13)
- BACKGROUNDMacMahon 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
- BACKGROUNDNaidich 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
- BACKGROUNDGould 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
- BACKGROUNDBerrington 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
- BACKGROUNDSmith-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
- BACKGROUNDSmith-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.