Clinical trial · Observational
Advancing Precision Lung Cancer Surveillance and Outcomes in Diverse Populations
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+
- 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 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
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 |
|---|---|---|---|
| Lung Cancer (Diagnosis) | Malignant Lung Neoplasm | CURATED_EXACT | 0.85 |
| Lung Neoplasms | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Non-Small Cell Lung Cancer (NSCLC), Stage I-IIIA | — | UNRESOLVED | — |
| Second Primary Lung Cancer (SPLC) | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Target population includes confirmed stage I-IIIA NSCLC patients within the OneFlorida+ Consortium
Primary outcomes (9)
- measure
- Guideline Adherence to Chest CT Surveillance
- timeFrame
- Up to 5 years after treatment completion
- description
- 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.
- measure
- Annual Rates of Guideline-Concordant Surveillance CT Imaging during post-treatment Years 1-5.
- timeFrame
- Year-specific rates are assessed annually for up to 5 years post-treatment.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available