Outcomes of Patients With Early and Locally Advanced Lung Cancer: Protocol for the Italian Lung Cancer Observational Study (LUCENT)

Background: Lung cancer, predominantly non-small cell lung cancer (NSCLC), remains a formidable challenge, necessitatingan in-depth understanding of evolving treatment paradigms. The Italian Lung Cancer Observational Study (LUCENT) addressesthis need by investigating the outcomes of patients with early and locally advanced lung cancer in Italy.Objective: With a focus on real-world data and patient registries, this study aims to provide comprehensive insights into clinical,psychosocial, and economic impacts, contributing to informed decision-making in health care.Methods: LUCENT is a prospective observational multicenter cohort study enrolling patients eligible for minimally invasivemanual, robot-assisted, or traditional open surgery. The study will develop a web-based registry to collect longitudinal surgical,oncological, and socioeconomic outcome data. The primary objectives include performance assessment through the establishmentof national benchmarks based on risk-adjusted outcomes and processes of care indicators. The secondary objectives encompasseconomic and psychosocial impact assessments of innovative technologies and treatment pathways. The multicenter designensures a diverse and representative study population.Results: The evolving landscape of NSCLC treatment necessitates a nuanced approach with consideration of the dynamic shiftsin therapeutic strategies. LUCENT strives to fill existing knowledge gaps by providing a platform for collecting and analyzingreal-world data, emphasizing the importance of patient-reported outcomes in enhancing the understanding of the disease. Bydeveloping a web-based registry, the study not only facilitates efficient data collection but also addresses the limitations oftraditional methods, such as suboptimal response rates and costs associated with paper-and-pencil questionnaires. Recruitmentwill be conducted from January 01, 2024, to December 31, 2026. Follow-up will be performed for a minimum of 2 years. Thestudy will be completed in the year 2028.Conclusions: LUCENT's potential implications are substantial. Establishing national benchmarks will enable a thoroughevaluation of outcomes and care processes, guiding clinicians and policymakers in optimizing patient management. Furthermore, the study's secondary objectives, focusing on economic and psychosocial impacts, align with the contemporary emphasis onholistic cancer care. Insights gained from this study may influence treatment strategies, resource utilization, and patient well-being,thereby contributing to the ongoing refinement of lung cancer management.