Department of Thoracic Surgery, IEO, European Institute of Oncology IRCCS, Milan, Italy.
Centre for Research on Health and Social Care Management (CERGAS), Bocconi School of Management, Bocconi University, Milan, Italy.
JMIR Res Protoc. 2024 Oct 8;13:e57183. doi: 10.2196/57183.
Lung cancer, predominantly non-small cell lung cancer (NSCLC), remains a formidable challenge, necessitating an in-depth understanding of evolving treatment paradigms. The Italian Lung Cancer Observational Study (LUCENT) addresses this need by investigating the outcomes of patients with early and locally advanced lung cancer in Italy.
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.
LUCENT is a prospective observational multicenter cohort study enrolling patients eligible for minimally invasive manual, 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 establishment of national benchmarks based on risk-adjusted outcomes and processes of care indicators. The secondary objectives encompass economic and psychosocial impact assessments of innovative technologies and treatment pathways. The multicenter design ensures a diverse and representative study population.
The evolving landscape of NSCLC treatment necessitates a nuanced approach with consideration of the dynamic shifts in therapeutic strategies. LUCENT strives to fill existing knowledge gaps by providing a platform for collecting and analyzing real-world data, emphasizing the importance of patient-reported outcomes in enhancing the understanding of the disease. By developing a web-based registry, the study not only facilitates efficient data collection but also addresses the limitations of traditional methods, such as suboptimal response rates and costs associated with paper-and-pencil questionnaires. Recruitment will be conducted from January 01, 2024, to December 31, 2026. Follow-up will be performed for a minimum of 2 years. The study will be completed in the year 2028.
LUCENT's potential implications are substantial. Establishing national benchmarks will enable a thorough evaluation 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 on holistic 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.
ClinicalTrials.gov NCT05851755; https://clinicaltrials.gov/study/NCT05851755. ISRCTN 67197140; https://www.isrctn.com/ISRCTN67197140.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/57183.
肺癌，主要是非小细胞肺癌（NSCLC），仍然是一个严峻的挑战，需要深入了解不断发展的治疗模式。意大利肺癌观察性研究（LUCENT）通过研究意大利早期和局部晚期肺癌患者的结局来满足这一需求。
本研究以真实世界数据和患者登记为重点，旨在提供对临床、心理社会和经济影响的全面了解，为医疗保健中的决策提供信息。
LUCENT 是一项前瞻性观察性多中心队列研究，招募适合微创手动、机器人辅助或传统开放手术的患者。该研究将开发一个基于网络的登记处，以收集纵向手术、肿瘤学和社会经济学结果数据。主要目标包括通过建立基于风险调整结果和护理过程指标的国家基准来评估绩效。次要目标包括评估创新技术和治疗途径的经济和心理社会影响。多中心设计确保了研究人群的多样性和代表性。
非小细胞肺癌治疗的不断发展需要一种细致入微的方法，考虑到治疗策略的动态变化。LUCENT 通过提供收集和分析真实世界数据的平台来努力填补现有知识空白，强调患者报告结果在增强对疾病理解方面的重要性。通过开发基于网络的登记处，该研究不仅促进了高效的数据收集，还解决了传统方法的局限性，例如响应率不理想和纸笔问卷相关的成本。招募将于 2024 年 1 月 1 日至 2026 年 12 月 31 日进行。随访时间至少为 2 年。研究将于 2028 年完成。
LUCENT 的潜在影响是巨大的。建立国家基准将能够彻底评估结果和护理过程，指导临床医生和决策者优化患者管理。此外，该研究的次要目标侧重于经济和心理社会影响，与当前对整体癌症护理的重视相一致。从这项研究中获得的见解可能会影响治疗策略、资源利用和患者的幸福感，从而有助于不断完善肺癌管理。
ClinicalTrials.gov NCT05851755；https://clinicaltrials.gov/study/NCT05851755。ISRCTN 67197140；https://www.isrctn.com/ISRCTN67197140。
国际注册报告标识符（IRRID）：PRR1-10.2196/57183。
