Advancing Precision Lung Cancer Surveillance and Outcomes in Diverse Populations (PLuS2)

推进不同人群的精准肺癌监测和结果 (PLuS2)

• 批准号: 10752848
• 负责人: Jiang Bian
• 金额: $ 55.65万
• 依托单位: UNIVERSITY OF FLORIDA
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-05 至 2028-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10752848
• 关键词: Adopted; Age; Alabama; American Society of Clinical Oncology; Body Weight decreased; Cancer Etiology; Cancer Intervention and Surveillance Modeling Network; Cancer Patient; Catalogs; Cessation of life; Characteristics; Chest Pain; Clinical; Clinical Research; Clinical Trials; Collaborations; Community Networks; Community Practice; Community of Practice; Coughing; Data; Data Sources; Decision Analysis; Decision Making; Detection; Diagnostic Imaging; Electronic Health Record; Ethnic Origin; European; Excision; Florida; Funding; Future; Geography; Goals; Guidelines; Image; Infrastructure; Knowledge; Lead; Malignant Neoplasms; Malignant neoplasm of lung; Modeling; Natural Language Processing; Non-Small-Cell Lung Carcinoma; Operative Surgical Procedures; Outcome; Patients; Pattern; Policies; Population; Population Heterogeneity; Prognosis; Prospective cohort; Public Health; Race; Radiology Specialty; Recommendation; Recurrence; Registries; Reporting; Research; Retrospective cohort; Scanning; Shortness of Breath; Smoking Status; Socioeconomic Status; Survival Rate; Symptoms; System; Thoracic Radiography; X-Ray Computed Tomography; black patient; clinical trial enrollment; comorbidity; comparative effectiveness; compare effectiveness; data integration; electronic health data; electronic structure; evidence based guidelines; improved; innovation; lung cancer screening; models and simulation; mortality; multimodality; participant enrollment; patient oriented; patient population; pulmonary function; randomized, clinical trials; repository; rurality; screening; social health determinants; sociodemographics; socioeconomics; study population; surveillance data; surveillance imaging; surveillance strategy; unstructured data; uptake

Due in part to recent advances in screening and treatment, the 5-year relative survival rate for patients with early-stage non-small cell lung cancer (NSCLC), the leading cause of cancer death worldwide, continues to increase each year. The uptake of guideline-recommended computed tomography (CT) imaging surveillance semiannually for 2 years and annually for up to 5 years following curative-intent therapy is increasing rapidly in the U.S., despite unclear evidence regarding its benefit in reducing mortality. Furthermore, clinical trials of CT imaging surveillance have not been reported among U.S. populations with NSCLC. This gap in research is alarming and portends a low quality of evidence in clinical guidelines. Currently, no comprehensive lung cancer surveillance data source exists that catalogs real-world lung cancer surveillance utilization patterns and downstream outcomes, both of which are necessary to develop evidence-based recommendations for surveillance following curative-intent therapy. This project, Advancing Precision Lung Cancer Surveillance and Outcomes in Diverse Populations (PLUS2), will create this unique data source to study, understand, and optimize lung cancer surveillance and downstream outcomes. Building on the extant infrastructure and preliminary data from the lung cancer screening registry of the PCORI- and NCI-funded OneFlorida+ Clinical Research Consortium, a network of community practices that serve Florida, Georgia, and Alabama, PLUS2 will leverage multilevel data from electronic health records, claims, and system-level factors for patients with early-stage NSCLC who have completed curative-intent therapy (n~27,217; median age 70) from 2012-2022 (retrospective cohort) and 2022-2025 (prospective cohort). The overarching goal of the project is to evaluate the comparative effectiveness of lung cancer surveillance strategies, principally semi-annual versus annual CT surveillance, in relation to long-term outcomes among diverse patients with early-stage NSCLC within the U.S. population. By generating previously unavailable real-world data from NCI’s Lung Cancer Intervention and Surveillance Modeling Network (CISNET) for use in validated simulation models, this proposal responds directly to calls to improve patient-centered decision-making in lung cancer surveillance candidates for whom the net benefits of surveillance are currently uncertain. This study is foundational for lung cancer surveillance practice change.

部分由于最近在筛查和治疗方面的进展，早期非小细胞肺癌(NSCLC)患者的5年相对存活率每年继续上升。NSCLC是全球癌症死亡的主要原因。在美国，治疗意向治疗后半年一次、持续两年一次、每年最多五年一次的CT影像监测正在迅速增加，尽管关于其在降低死亡率方面的益处的证据尚不清楚。此外，CT成像监测在美国非小细胞肺癌患者中的临床试验尚未见报道。研究中的这一差距令人担忧，预示着临床指南中的证据质量较低。目前，还没有全面的肺癌监测数据来源来分类真实世界的肺癌监测利用模式和下游结果，这两者都是为治疗性意图治疗后的监测制定循证建议所必需的。这项名为“推进不同人群中的精确肺癌监测和结果(PLU2)”的项目将创建这一独特的数据来源，以研究、了解和优化肺癌监测和下游结果。在PCORI和NCI资助的One佛罗里达+临床研究联盟(一个服务于佛罗里达州、佐治亚州和阿拉巴马州的社区实践网络)肺癌筛查登记的现有基础设施和初步数据的基础上，Plus2将利用来自电子健康记录、索赔和系统层面因素的多层次数据，这些患者在2012-2022年(回顾队列)和2022-2025年(前瞻性队列)期间完成了治疗意图治疗(n~27,217；中位数70岁)。该项目的总体目标是评估肺癌监测策略的比较有效性，主要是半年一次和一年一次的CT监测，与美国人口中不同的早期非小细胞肺癌患者的长期结果相关。通过从NCI的肺癌干预和监测建模网络(CISNET)生成以前无法获得的真实世界数据，以用于经过验证的模拟模型，这项建议直接响应了要求改善肺癌监测候选人以患者为中心的决策的呼声，对这些候选人来说，监测的净效益目前尚不确定。本研究为肺癌监测实践的变革奠定了基础。