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+
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,826
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.