Advancing Precision Lung Cancer Surveillance and Outcomes in Diverse Populations

NCT07581379 | Active Not Recruiting

• 2 other identifiers: IRB202300782R01CA284646
• Study Type: observational
• Target: 1,826
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (9)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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)

  0-5 years post treatment

• CT Surveillance Utilization Rate

  Up to 5 years post treatment

• False Positive Surveillance CT Results

  Up to 5 years

• Downstream Diagnostic Procedures After Surveillance CT

  Up to 5 years following treatment completion

• Procedure Related Complications

  Up to 5 years following treatment completion

Other Outcomes (2)

• Model Projected Recurrence/SPLC Detection Timing and Mode

  From the index surveillance decision through the model-projected lifetime horizon (5 years, 10 years)

• Model Projected Population Impact Under Varying Surveillance Uptake

  Over the model-projected lifetime horizon after the index surveillance decision (5 years, 10 years)

Study Arms (1)

Target population includes confirmed stage I-IIIA NSCLC patients within the OneFlorida+ Consortium

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• University of Florida: lead
• National Cancer Institute (NCI): collaborator
• Kaiser Permanente: collaborator

Study Sites (1)

University of Florida College of Medicine

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Disease

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2026
• First Posted: May 12, 2026
• Study Start: January 1, 2012
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)