Lung NeoplasmsPLuS2NCT07581379

Advancing Precision Lung Cancer Surveillance and Outcomes in Diverse Populations

An observational study of Lung Neoplasms and Second Primary Lung Cancer (SPLC), run by University of Florida at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

This observational study evaluates the effectiveness of computed tomography (CT) imaging surveillance after curative-intent treatment for stage I-IIIA non-small cell lung cancer (NSCLC) in a diverse U.S. population. Read more about this study

Who is it for?: Any age
Conditions the study is for: Lung Neoplasms, Second Primary Lung Cancer (SPLC), Non-Small Cell Lung Cancer (NSCLC), Stage I-IIIA
How many people: 1,826 participants
Where: 1 siteUnited States
Study dates: Jan 2012to Dec 2026
Phase: Observational
Are there results?: Not yet: the study is under way

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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: The study population includes adults diagnosed with primary, pathologically confirmed stage I-IIIA non-small cell lung cancer (NSCLC) who received curative intent therapy (surgery or SBRT ± adjuvant therapy) within the UF Health system and are captured in the OneFlorida+ data network. Eligible patients must have completed treatment and survived ≥5 months to allow surveillance assessment. Structured EHR, tumor registry data, and unstructured clinical documentation will be used, with NLP applied to classify surveillance vs. symptom-directed imaging and extract clinical, functional, and social determinants of health.

Who may be able to join

Adults diagnosed with primary, pathologically confirmed stage I-IIIA non- small cell lung cancer (NSCLC).
Received curative-intent therapy, including:
Surgical resection, or Stereotactic body radiation therapy (SBRT), with or without adjuvant therapy.
Completed curative-intent therapy and survived at least 5 months after therapy initiation.
Received care within the University of Florida (Gainesville or Jacksonville) health system, and are included in the OneFlorida+ clinical data network.
Have available:
Structured EHR data (including tumor registry linkage, imaging, procedures, and vital statistics), and Unstructured clinical documents (clinic notes, radiology reports, pathology reports) enable NLP extraction.
Have ≥1 follow-up encounter in the EHR after treatment completion to allow surveillance assessment.

Who cannot join

Histology other than NSCLC, including:
Small-cell lung cancer Carcinoid tumors Rare non-NSCLC primary tumors
Metastatic disease (stage IV) at diagnosis.
No curative-intent therapy received (e.g., palliative treatment only).
Patients with incomplete treatment records prevent the determination of the treatment completion date.
Patients with no surveillance-relevant follow-up data, including:

Show all 10Show fewer

No post-treatment clinical notes No radiology/pathology records No linked tumor registry or vital status data
Patients with recurrence or who die within the first 5 months after starting curative-intent therapy (insufficient window for guideline-defined surveillance).
Patients with missing identifiers prevent linkage to cancer registries or the death index.
Individuals whose imaging cannot be classified as surveillance vs. diagnostic due to the absence of relevant structured or unstructured data.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Florida College of Medicine
Gainesville, Florida, 32610

Other trials in United States

About this study

Official title: Protocol for an Observational Cohort Study Integrating Real-World Data and Microsimulation to Assess Imaging Surveillance Strategies in Stage I-IIIA NSCLC Patients in OneFlorida+

The main questions are:

How do CT surveillance use and adherence vary by race, ethnicity, and socioeconomic status?

Does semi-annual CT surveillance improve outcomes compared with annual surveillance?

Adults ages 20-90 with stage I-IIIA NSCLC treated between 2012 and 2026 will be identified using OneFlorida+ electronic health records, tumor registry data, claims, and clinical notes. Patients will be followed for up to five years after curative-intent therapy to evaluate surveillance patterns, recurrence, second primary lung cancers, complications, and survival.

Read the detailed description

This study, Advancing Precision Lung Cancer Surveillance and Outcomes in Diverse Populations (PLuS2), is an observational cohort study designed to evaluate real-world computed tomography (CT) imaging surveillance strategies following curative-intent treatment for early-stage non-small cell lung cancer (NSCLC). The study uses existing clinical data and does not assign interventions.

The study population includes adults ages 20-90 with pathologically confirmed stage I-IIIA NSCLC who completed curative-intent therapy. Patients treated between 2012 and 2026 will be identified within the OneFlorida+ Clinical Research Consortium and followed for up to five years after treatment to assess surveillance patterns and outcomes.

UF Health serves as the data coordinating site in collaboration with the OneFlorida+ Data Trust. Data sources include structured electronic health records, tumor registry data, selected claims, and unstructured clinical notes. Data extraction and cohort identification are conducted centrally using standardized definitions aligned with the PCORnet Common Data Model.

The primary objectives of the study are to:

Describe utilization and adherence to guideline-recommended CT surveillance and evaluate determinants of use by race, ethnicity, socioeconomic status, and clinical factors.
Compare recurrence, second primary lung cancers, complications, and survival among patients undergoing semi-annual versus annual CT surveillance.
Use observational findings to inform microsimulation models that project long-term outcomes under alternative surveillance strategies.

Clinical natural language processing (NLP) methods are used to classify CT scans as routine surveillance versus symptom-directed diagnostic imaging and to extract recurrence indicators, smoking history, and selected social determinants of health from unstructured clinical notes. NLP outputs are integrated with structured data to improve classification accuracy and completeness.

Quality assurance procedures include automated checks for completeness, range, and internal consistency, validation against source EHR and tumor registry records, and maintenance of a standardized data dictionary defining all variables and coding systems. Standard operating procedures govern cohort assembly, quarterly data refreshes, data management, analysis, and reporting.

The expected cohort size is approximately 1,700 patients, providing sufficient power to evaluate surveillance utilization patterns and outcome differences by surveillance interval. Missing data will be addressed using multiple imputation and sensitivity analyses.

Statistical analyses include descriptive methods, multivariable and mixed-effects regression models, and time-to-event and competing-risk analyses. Results from the observational analyses will be used as inputs for microsimulation modeling to estimate long-term population-level outcomes associated with different CT surveillance strategies.

Conditions: Lung Neoplasms, Second Primary Lung Cancer (SPLC), Non-Small Cell Lung Cancer (NSCLC), Stage I-IIIA, Lung Cancer (Diagnosis)
Keywords: Non-small cell lung cancer, Lung cancer surveillance, CT imaging, Post-treatment surveillance, Cancer recurrence, Second primary lung cancer, Survival, Electronic health records, Real-world data
Medical subject headings: Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07581379
Study group	Role	What they receive
Target population includes confirmed stage I-IIIA NSCLC patients within the OneFlorida+ Consortium		Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Guideline Adherence to Chest CT Surveillance
Proportion of patients who complete guideline-recommended post-treatment chest CT surveillance within prespecified rolling surveillance windows. Guideline adherence will be defined using ±1-month and ±2-month allowable windows around each recommended surveillance time point. Semi-annual surveillance (Years 0-2) will be assessed at recommended months 6, 12, 18, and 24, with adherence defined as completing a CT within months 5-7 or 4-8, 11-13 or 10-14, 17-19 or 16-20, and 23-25 or 22-26, respectively. Annual surveillance (Years 3-5) will be assessed at recommended months 36, 48, and 60, with adherence defined as completing a CT within months 35-37 or 34-38, 47-49 or 46-50, and 59-61 or 58-62, respectively. Patients will be censored at recurrence, death, loss to follow-up, or end of study.
Measured: Up to 5 years after treatment completion
Annual Rates of Guideline-Concordant Surveillance CT Imaging during post-treatment Years 1-5.
Surveillance begins at completion of curative-intent therapy (surgery or SBRT ± adjuvant therapy), and only routine surveillance scans are included. In Years 1-2, surveillance is guideline-concordant if CTs are completed within rolling 4-8-month intervals following either treatment completion or the prior surveillance CT. In Years 3-5, surveillance is guideline-concordant if CTs occur within rolling 10-14-month intervals from the prior CT. Patients are censored at recurrence, death, loss to follow-up, or end of study period.
Measured: Year-specific rates are assessed annually for up to 5 years post-treatment.
Time to First Recurrence
Time from completion of curative-intent therapy to the first documented cancer recurrence (local, regional, or distant). Recurrence will be identified using structured electronic health records (EHR) recurrence fields, validated recurrence-detection algorithms, cancer registry linkage, and natural language processing (NLP) based extraction from radiology reports and clinical notes. Patients will be censored at death without recurrence, loss to follow-up, or completion of 5-year follow-up.
Measured: Up to 5 years post-treatment.
Time to Second Primary Lung Cancer (SPLC)
Time from completion of curative-intent therapy to diagnosis of a metachronous second primary lung cancer (SPLC). SPLC will be defined using standard criteria, including AJCC TNM staging, histologic distinction from the index tumor, cancer registry confirmation, and pathology report verification. Among patients who develop SPLC, we will evaluate stage at SPLC diagnosis, histologic subtype (including bronchioloalveolar carcinoma), and receipt of adjuvant therapy. Patients will be censored at death without SPLC, recurrence without SPLC, or completion of follow-up. This outcome will be analyzed as a time-to-event measure consistent with other survival endpoints.
Measured: Up to 5 years or end of follow up
All-cause mortality
Time from completion of curative intent treatment to death from any cause. Vital status will be ascertained through institutional cancer registries, the National Death Index, and state death certificate data.
Measured: Up to 5 years post-treatment (or longest available follow-up).
Lung Cancer-Specific Mortality
Time from completion of curative-intent treatment to death attributed specifically to lung cancer, analyzed under a competing-risk framework in which non-lung cancer deaths are treated as competing events. Cause of death will be determined using institutional cancer registry data and National Death Index linkage.
Measured: Up to 5 years following treatment completion.
Mode of Recurrence Detection
Classification of recurrence mode at the time of first recurrence. Recurrences will be categorized as:
1. Surveillance detected: Identified during routine surveillance CT imaging in asymptomatic patients.
2. Symptom detected: Identified after clinical symptoms prompted diagnostic evaluation.
Detection mode will be determined using electronic health record (EHR) documentation and natural language processing (NLP) extraction from radiology reports and clinical notes. Timing of recurrence (time to event) will be evaluated separately; early vs. later surveillance detection will be described, but has no clinical implications if timing windows shift.
Measured: Assessed at the time of recurrence, up to 5 years following treatment completion.
Type of SPLC Detection
Classification of metachronous second primary lung cancer (SPLC) as either:
Surveillance-detected: Identified during routine surveillance CT imaging in asymptomatic patients.
Symptom-detected: Identified after new or worsening symptoms prompted diagnostic evaluation.
Detection mode will be determined using EHR documentation and NLP extraction from radiology reports and clinical notes.
Measured: At SPLC diagnosis (≤5 years following treatment completion).
Model-Projected Long-Term Survival Under Alternative Surveillance Strategies
Microsimulation-projected overall and lung cancer-specific survival under semi-annual versus annual CT surveillance schedules. The model will be calibrated using recurrence, SPLC, and mortality data from Aims 1-2 and extrapolated to national incidence patterns using SEER data.
Measure Description:
Difference in projected survival outcomes between semi-annual and annual surveillance strategies, reported as:
1. Mean life expectancy (life-years)
2. Five-year, ten-year, and lifetime survival probabilities
3. Hazard of lung cancer-specific death
Model estimates will be derived from a calibrated Markov microsimulation model informed by Aims 1-2 and extrapolated using SEER incidence.
Measured: At 5 years, 10 years, and over the model-projected lifetime horizon after the index surveillance decision

Secondary outcomes (7)

CT Surveillance Pattern Classification (0-5 Years)
Patients will be categorized into one of four mutually exclusive surveillance patterns based on completed post-treatment surveillance CT imaging from 0-5 years following curative intent therapy:
1. Semi-Annual Adherence: Consistent completion of surveillance CT scans within guideline-concordant 4-8 month intervals during Years 1-2, followed by 10-14 month intervals during Years 3-5.
2. Annual Only Adherence: Completion of at least annual surveillance (10-14 month intervals) during Years 1-5, but not meeting semi-annual criteria in Years 1-2.
3. Irregular/Other Surveillance: Completion of ≥1 surveillance CT scan during follow-up, but not meeting semi-annual or annual adherence definitions.
4. No Surveillance: No documented surveillance CT scan within 12 months of treatment completion.
Measured: 0-5 years post treatment
CT Surveillance Utilization Rate
Intensity of surveillance CT use, measured as scans per person time and/or completion of guideline-recommended surveillance intervals
Measured: Up to 5 years post treatment
False Positive Surveillance CT Results
Surveillance CT scans that trigger additional diagnostic evaluation (biopsy, PET CT, or repeat imaging) without a lung cancer diagnosis (recurrence or SPLC) within 6 months of the index scan. Results will be classified as true positive, false positive, true negative, or false negative using cancer registry data and EHR documentation
Measured: Up to 5 years
Downstream Diagnostic Procedures After Surveillance CT
Frequency and type of diagnostic procedures, both invasive and non-invasive, performed following surveillance CT imaging, including transthoracic biopsy, transbronchial biopsy, bronchoscopy, and PET-CT.
Measured: Up to 5 years following treatment completion
Procedure Related Complications
Complications occurring within 7 days and 30 days of invasive diagnostic procedures (transthoracic, transbronchial, or surgical biopsies), including:
1. Pneumothorax
2. Pulmonary hemorrhage
3. Acute respiratory failure
4. Acute renal failure
5. Contrast allergy requiring hospitalization
6. Acute myocardial infarction
Measured: Up to 5 years following treatment completion
Recurrence Site / Pattern (Registry Based)
Classification of recurrence site as local, regional, or distant, based on cancer registry definitions.
Measured: At recurrence (≤5 years)
Receipt of Treatment Following Recurrence or SPLC
Time to treatment initiation following recurrence or SPLC diagnosis, and classification of treatment modality, including surgery, SBRT, targeted therapy, and immune checkpoint inhibitor therapy.
Measured: At recurrence or SPLC diagnosis (≤5 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2012Dec 2026

First posted12 May 2026
Study startJan 2012
Primary completionDec 2026 (estimated)
Study completionDec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
More trials run by University of FloridaThe sponsor's other registered studies.
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: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 1,826 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07581379
Sponsor's protocol ID: IRB202300782
Other IDs: R01CA284646
Acronym: PLuS2
Status last verified: Jan 2026
First submitted: 1 May 2026
Last updated: 12 May 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Protocol for an Observational Cohort Study Integrating Real-World Data and Microsimulation to Assess Imaging Surveillance Strategies in Stage I-IIIA NSCLC Patients in OneFlorida+
ClinicalTrials.gov ID: NCT07581379
Acronym / sponsor ID: PLuS2 / IRB202300782
Conditions: Lung Neoplasms, Second Primary Lung Cancer (SPLC), Non-Small Cell Lung Cancer (NSCLC), Stage I-IIIA, Lung Cancer (Diagnosis)
Keywords: Non-small cell lung cancer, Lung cancer surveillance, CT imaging, Post-treatment surveillance, Cancer recurrence, Second primary lung cancer, Survival, Electronic health records
Study type: Observational
Recruitment status: Active, not recruiting
Enrolment: 1,826 participants (actual)
Lead sponsor: University of FloridaUniversity, hospital or other
Collaborators: National Cancer Institute (NCI), Kaiser Permanente
Study start: Jan 2012 (actual)
Primary completion: Dec 2026 (estimated)
Study completion: Dec 2026 (estimated)
First posted: 12 May 2026 (actual)
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.

The main questions are:

How do CT surveillance use and adherence vary by race, ethnicity, and socioeconomic status?

Does semi-annual CT surveillance improve outcomes compared with annual surveillance?

Detailed description

The primary objectives of the study are to:

Describe utilization and adherence to guideline-recommended CT surveillance and evaluate determinants of use by race, ethnicity, socioeconomic status, and clinical factors.
Compare recurrence, second primary lung cancers, complications, and survival among patients undergoing semi-annual versus annual CT surveillance.
Use observational findings to inform microsimulation models that project long-term outcomes under alternative surveillance strategies.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
Target population includes confirmed stage I-IIIA NSCLC patients within the OneFlorida+ Consortium	–	–

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: The study population includes adults diagnosed with primary, pathologically confirmed stage I-IIIA non-small cell lung cancer (NSCLC) who received curative intent therapy (surgery or SBRT ± adjuvant therapy) within the UF Health system and are captured in the OneFlorida+ data network. Eligible patients must have completed treatment and survived ≥5 months to allow surveillance assessment. Structured EHR, tumor registry data, and unstructured clinical documentation will be used, with NLP applied to classify surveillance vs. symptom-directed imaging and extract clinical, functional, and social determinants of health.

Key inclusion criteria (8 listed)

Adults diagnosed with primary, pathologically confirmed stage I-IIIA non- small cell lung cancer (NSCLC).
Received curative-intent therapy, including:
Surgical resection, or Stereotactic body radiation therapy (SBRT), with or without adjuvant therapy.
Completed curative-intent therapy and survived at least 5 months after therapy initiation.
Received care within the University of Florida (Gainesville or Jacksonville) health system, and are included in the OneFlorida+ clinical data network.

Key exclusion criteria (10 listed)

Histology other than NSCLC, including:
Small-cell lung cancer Carcinoid tumors Rare non-NSCLC primary tumors
Metastatic disease (stage IV) at diagnosis.
No curative-intent therapy received (e.g., palliative treatment only).
Patients with incomplete treatment records prevent the determination of the treatment completion date.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Guideline Adherence to Chest CT Surveillance
Time frame: Up to 5 years after treatment completion
Proportion of patients who complete guideline-recommended post-treatment chest CT surveillance within prespecified rolling surveillance windows. Guideline adherence will be defined using ±1-month and ±2-month allowable windows around each recommended surveillance time point. Semi-annual surveillance (Years 0-2) will be assessed at recommended months 6, 12, 18, and 24, with adherence defined as completing a CT within months 5-7 or 4-8, 11-13 or 10-14, 17-19 or 16-20, and 23-25 or 22-26, respectively. Annual surveillance (Years 3-5) will be assessed at recommended months 36, 48, and 60, with adherence defined as completing a CT within months 35-37 or 34-38, 47-49 or 46-50, and 59-61 or 58-62, respectively. Patients will be censored at recurrence, death, loss to follow-up, or end of study.
Annual Rates of Guideline-Concordant Surveillance CT Imaging during post-treatment Years 1-5.
Time frame: Year-specific rates are assessed annually for up to 5 years post-treatment.
Surveillance begins at completion of curative-intent therapy (surgery or SBRT ± adjuvant therapy), and only routine surveillance scans are included. In Years 1-2, surveillance is guideline-concordant if CTs are completed within rolling 4-8-month intervals following either treatment completion or the prior surveillance CT. In Years 3-5, surveillance is guideline-concordant if CTs occur within rolling 10-14-month intervals from the prior CT. Patients are censored at recurrence, death, loss to follow-up, or end of study period.
Time to First Recurrence
Time frame: Up to 5 years post-treatment.
Time from completion of curative-intent therapy to the first documented cancer recurrence (local, regional, or distant). Recurrence will be identified using structured electronic health records (EHR) recurrence fields, validated recurrence-detection algorithms, cancer registry linkage, and natural language processing (NLP) based extraction from radiology reports and clinical notes. Patients will be censored at death without recurrence, loss to follow-up, or completion of 5-year follow-up.
Time to Second Primary Lung Cancer (SPLC)
Time frame: Up to 5 years or end of follow up
Time from completion of curative-intent therapy to diagnosis of a metachronous second primary lung cancer (SPLC). SPLC will be defined using standard criteria, including AJCC TNM staging, histologic distinction from the index tumor, cancer registry confirmation, and pathology report verification. Among patients who develop SPLC, we will evaluate stage at SPLC diagnosis, histologic subtype (including bronchioloalveolar carcinoma), and receipt of adjuvant therapy. Patients will be censored at death without SPLC, recurrence without SPLC, or completion of follow-up. This outcome will be analyzed as a time-to-event measure consistent with other survival endpoints.
All-cause mortality
Time frame: Up to 5 years post-treatment (or longest available follow-up).
Time from completion of curative intent treatment to death from any cause. Vital status will be ascertained through institutional cancer registries, the National Death Index, and state death certificate data.
Lung Cancer-Specific Mortality
Time frame: Up to 5 years following treatment completion.
Time from completion of curative-intent treatment to death attributed specifically to lung cancer, analyzed under a competing-risk framework in which non-lung cancer deaths are treated as competing events. Cause of death will be determined using institutional cancer registry data and National Death Index linkage.
Mode of Recurrence Detection
Time frame: Assessed at the time of recurrence, up to 5 years following treatment completion.
Classification of recurrence mode at the time of first recurrence. Recurrences will be categorized as: 1. Surveillance detected: Identified during routine surveillance CT imaging in asymptomatic patients. 2. Symptom detected: Identified after clinical symptoms prompted diagnostic evaluation. Detection mode will be determined using electronic health record (EHR) documentation and natural language processing (NLP) extraction from radiology reports and clinical notes. Timing of recurrence (time to event) will be evaluated separately; early vs. later surveillance detection will be described, but has no clinical implications if timing windows shift.
Type of SPLC Detection
Time frame: At SPLC diagnosis (≤5 years following treatment completion).
Classification of metachronous second primary lung cancer (SPLC) as either: Surveillance-detected: Identified during routine surveillance CT imaging in asymptomatic patients. Symptom-detected: Identified after new or worsening symptoms prompted diagnostic evaluation. Detection mode will be determined using EHR documentation and NLP extraction from radiology reports and clinical notes.
Model-Projected Long-Term Survival Under Alternative Surveillance Strategies
Time frame: At 5 years, 10 years, and over the model-projected lifetime horizon after the index surveillance decision
Microsimulation-projected overall and lung cancer-specific survival under semi-annual versus annual CT surveillance schedules. The model will be calibrated using recurrence, SPLC, and mortality data from Aims 1-2 and extrapolated to national incidence patterns using SEER data. Measure Description: Difference in projected survival outcomes between semi-annual and annual surveillance strategies, reported as: 1. Mean life expectancy (life-years) 2. Five-year, ten-year, and lifetime survival probabilities 3. Hazard of lung cancer-specific death Model estimates will be derived from a calibrated Markov microsimulation model informed by Aims 1-2 and extrapolated using SEER incidence.

7 secondary outcomes

CT Surveillance Pattern Classification (0-5 Years)
Time frame: 0-5 years post treatment
CT Surveillance Utilization Rate
Time frame: Up to 5 years post treatment
False Positive Surveillance CT Results
Time frame: Up to 5 years
Downstream Diagnostic Procedures After Surveillance CT
Time frame: Up to 5 years following treatment completion
Procedure Related Complications
Time frame: Up to 5 years following treatment completion
Recurrence Site / Pattern (Registry Based)
Time frame: At recurrence (≤5 years)
Receipt of Treatment Following Recurrence or SPLC
Time frame: At recurrence or SPLC diagnosis (≤5 years)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
Individual participant dataSharing planned: No

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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Neoplasms and Second Primary Lung Cancer (SPLC), run by University of Florida 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 8 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 12 May 2026. 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?

This study is still under way. Results are not available in the source record yet.

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?

Guideline Adherence to Chest CT Surveillance (time frame: Up to 5 years after treatment completion). The study lists 9 primary outcomes in all. 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 NCT07581379.

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 12 May 2026.