Solitary Pulmonary NoduleWTSNCT02623712
The Watch the Spot Trial
A study testing More Frequent Surveillance Strategy and Less Frequent Surveillance Strategy in people with Solitary Pulmonary Nodule and Coin Lesion, Pulmonary, run by Kaiser Permanente at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Solitary Pulmonary Nodule, Coin Lesion, Pulmonary, Lung Neoplasms
- What is being tested?
- More Frequent Surveillance Strategy and Less Frequent Surveillance Strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34,686 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2017to 4 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pregnant Women
- Age <35 years
- Known diagnosis of cancer (except non-melanoma skin cancer) within 5 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Southern California
Pasadena, California, 91011
About this study
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
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.
Read the detailed 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.
- Conditions
- Solitary Pulmonary Nodule, Coin Lesion, Pulmonary, Lung Neoplasms, Carcinoma, Non-small-cell Lung
- Being tested
- More Frequent Surveillance Strategy, Less Frequent Surveillance Strategy
- Medical subject headings
- Solitary Pulmonary Nodule, Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
More Frequent Surveillance StrategyOther
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 StrategyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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. Receives: Other: Less Frequent Surveillance Strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months after enrollment
Secondary outcomes (9)
Number of days from date of nodule identification to date of cancer diagnosis
Ongoing, final analysis in year 5
Measured: Up to 2 years
Survival time from date of cancer diagnosis until death or end of study
Ongoing, final analysis in year 5
Measured: Up to 4 years
Emotional distress, measured with the Impact of Events Scale
Compare patient-reported emotional distress
Measured: Measured at 2 months, 13 months, and 25 months following nodule identification
Anxiety, measured with the State Anxiety Inventory, 6-item
Compare patient-reported anxiety
Measured: Measured at 2 months, 13 months, and 25 months following nodule identification
General health status, measured with a single question
Compare patient-reported general health status
Measured: Measured at 2 months, 13 months, and 25 months following nodule identification
Numbers of imaging tests, biopsy tests and surgical procedures, measured by review of electronic health records
Compare resource utilization.
Measured: Measured from date of nodule identification until date of cancer diagnosis or completion of 24 months of follow-up
Exposure to ionizing radiation, using the computed tomography dose index (CTDIvol), measured in mGy (milliGray)
Compare effective radiation doses received.
Measured: Measured from date of nodule identification to date of cancer diagnosis or completion of 24 months of follow-up
Exposure to ionizing radiation, using the the dose length product (DLP), measured in mGy*cm
Compare effective radiation doses received.
Measured: Measured from date of nodule identification to date of cancer diagnosis or completion of 24 months of follow-up
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: Measured from date of nodule identification to date of cancer diagnosis or completion of 24 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2015 (estimated)
- Study start6 Mar 2017
- Primary completion4 Sep 2024
- Study completion4 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Solitary Pulmonary NoduleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34,686 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, University of California, Davis, University of California, San Francisco
- Responsible party
- Principal investigator, Michael K Gould, MD, Kaiser Permanente
- Investigators
- Michael K Gould, MD, MS, Principal investigator, Kaiser Permanente School of Medicin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02623712
- Sponsor's protocol ID
- 1000001
- Acronym
- WTS
- Status last verified
- Aug 2025
- First submitted
- 1 Dec 2015
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share de-identified IPD for all study variables with other researchers on request as long as there is an acceptable justification
Publications
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.
PubMed 16244247Naidich 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.
PubMed 23070270Gould 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.
PubMed 23649456Berrington 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.
PubMed 20008689Smith-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.
PubMed 20573919Smith-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.
PubMed 22692172Gould 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.
PubMed 26214244Wiener 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.
PubMed 24710850Brenner 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.
PubMed 18046031Ost 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.
PubMed 12815140Gould MK, Creekmur B, Qi L, de Bie E, Aberle DR, Dyer DS, Golden S, Kaplan CP, Mularski RA, Steiner JS, Steltz JP, Vachani A, Wiener RS, Kelly K, Smith-Bindman R, Miglioretti DL. Less Versus More Intensive Surveillance of Pulmonary Nodules Detected Incidentally or by Screening: A Survey of Radiologist Beliefs About Guidelines Implemented in the Watch the Spot Trial. J Am Coll Radiol. 2025 Dec;22(12):1589-1597. doi: 10.1016/j.jacr.2025.09.022.
PubMed 41338713Gould 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.
PubMed 40518364Gould 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.
PubMed 37356710
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02623712
- Acronym / sponsor ID
- WTS / 1000001
- Conditions
- Solitary Pulmonary Nodule, Coin Lesion, Pulmonary, Lung Neoplasms, Carcinoma, Non-small-cell Lung
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34,686 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, University of California, Davis, University of California, San Francisco
- Study start
- 6 Mar 2017 (actual)
- Primary completion
- 4 Sep 2024 (actual)
- Study completion
- 4 Sep 2024 (actual)
- First posted
- 8 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| More Frequent CT Surveillance | Active comparator | Other: More Frequent Surveillance StrategyChest 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 CT Surveillance | Active comparator | Other: Less Frequent Surveillance StrategyChest 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. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Pregnant Women
- Age <35 years
- Known diagnosis of cancer (except non-melanoma skin cancer) within 5 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| More Frequent Surveillance StrategyChest 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 CT Surveillance |
| Less Frequent Surveillance StrategyChest 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 CT Surveillance |
Primary outcome
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.
9 secondary outcomes
Number of days from date of nodule identification to date of cancer diagnosis
Time frame: Up to 2 years
Survival time from date of cancer diagnosis until death or end of study
Time frame: Up to 4 years
Emotional distress, measured with the Impact of Events Scale
Time frame: Measured at 2 months, 13 months, and 25 months following nodule identification
Anxiety, measured with the State Anxiety Inventory, 6-item
Time frame: Measured at 2 months, 13 months, and 25 months following nodule identification
General health status, measured with a single question
Time frame: Measured at 2 months, 13 months, and 25 months following nodule identification
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Background: PubMed 16244247MacMahon 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.
- Background: PubMed 23070270Naidich 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.
- Background: PubMed 23649456Gould 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.
- Background: PubMed 20008689Berrington 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.
- Background: PubMed 20573919Smith-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.
- Background: PubMed 22692172Smith-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.
- Background: PubMed 26214244Gould 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.
- Background: PubMed 24710850Wiener 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.
- Background: PubMed 18046031Brenner 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.
- Background: PubMed 12815140Ost 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.
- Derived from this study: PubMed 41338713Gould MK, Creekmur B, Qi L, de Bie E, Aberle DR, Dyer DS, Golden S, Kaplan CP, Mularski RA, Steiner JS, Steltz JP, Vachani A, Wiener RS, Kelly K, Smith-Bindman R, Miglioretti DL. Less Versus More Intensive Surveillance of Pulmonary Nodules Detected Incidentally or by Screening: A Survey of Radiologist Beliefs About Guidelines Implemented in the Watch the Spot Trial. J Am Coll Radiol. 2025 Dec;22(12):1589-1597. doi: 10.1016/j.jacr.2025.09.022.
- Derived from this study: PubMed 40518364Gould 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.
- Individual participant dataSharing planned: Yes. We plan to share de-identified IPD for all study variables with other researchers on request as long as there is an acceptable justification
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael K Gould, MD, MS principal investigator
Kaiser Permanente School of Medicin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing More Frequent Surveillance Strategy and Less Frequent Surveillance Strategy in people with Solitary Pulmonary Nodule and Coin Lesion, Pulmonary, run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02623712, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.