The Lymphoma Epidemiology of Outcomes (LEO) Cohort Study

项目总结 2020年，美国估计将有77,240人被诊断为非霍奇金淋巴瘤(NHL)，以及 19940人将死于这种癌症。非霍奇金淋巴瘤的发病率在20世纪后半叶有所增加，只有 最近稳定下来了。与此同时，非霍奇金淋巴瘤的存活率在20世纪90年代中期开始改善， 改进的治疗策略，导致目前的5年存活率为74%。这些趋势导致了 非霍奇金淋巴瘤幸存者人数增长，2019年估计超过757,000人。解决未得到满足的健康问题 为了满足这一患者群体的需求，我们建立了淋巴瘤流行病学(LEO)队列研究， 到2020年6月，该中心将招募超过13,000名NHL患者，并有1%的患者失去了随访。狮子座 队列支持多项赠款，并对NHL预后和 生存能力。为了继续和扩大LEO的主要贡献，在这次更新中，我们建议：1)扩展 在所有8个LEO中心招募，目标是招募3400名新诊断的NHL患者，重点是 西班牙裔(N=900)、非裔美国人(N=580)和亚裔(N=200)参与者(当前样本翻了一番 这些群体的规模)和18-39岁的青少年和青年(Aya)参与者(N=870；87% 增加)，以及所有年龄和种族/族裔的非城市和农村患者(N=1,208，增加72%)，总计 16,500名患者的队列；2)审查所有病理诊断并维护NHL肿瘤库，其中包括 组织微阵列中的H&E玻片、福尔马林固定、石蜡包埋的组织样本，并提取肿瘤DNA 和RNA；3)采集外周血样并维护DNA、血清、血浆的中央生物库 和Buffy Coat；4)用临床、流行病学、病理学和治疗数据注释和协调所有病例， 包括开发新的信息学增强功能，以从电子健康记录中捕获临床数据， 数字病理图像和与公共数据库的链接，以加强环境暴露数据和 社会经济因素；5)前瞻性地跟踪队列中的患者以确定疾病进展/复发， 再治疗、转化、第二次癌症、存活率(包括死因)、最新暴露、患者- 报告结果(PRO)和其他长期健康结果；以及6)促进使用 这一基础设施促进了与NCI支持的临床试验网络、患者倡导团体、 和其他合作者。我们将通过每个参与者的密切协调来实现这些目标 中心，由四个核心支持(行政、临床、病理学和生物谱学；以及生物统计和 信息学)。LEO队列是一种特殊的资源，它支持旨在 确定影响非霍奇金淋巴瘤的新的临床、流行病学、生殖系遗传、肿瘤和治疗因素 关注阿亚族、少数民族和农村人口NCI研究重点的预后和生存。狮子座是 由非霍奇金淋巴瘤临床和流行病学研究的国际专家领导，从而推动了 给临床和人群带来了新的发现。

PROJECT SUMMARY In 2020, an estimated 77,240 people in the US will be diagnosed with non-Hodgkin lymphoma (NHL), and 19,940 will die from this cancer. NHL incidence rates increased over the last half of the 20th century and only recently stabilized. In parallel, NHL survival rates began improving in the mid-1990s with the advent of improved treatment strategies, leading to the current 5-year survival rate of 74%. These trends have led to a growth in the number of NHL survivors, estimated at over 757,000 in 2019. To address the unmet health needs of this patient population, we established the Lymphoma Epidemiology of Outcomes (LEO) cohort study, which by June 2020 will have enrolled over 13,000 NHL patients and have <1% lost to follow-up. The LEO cohort supports multiple grants and has generated novel and high impact findings on NHL prognosis and survivorship. To continue and expand the key contributions of LEO, in this renewal we propose to: 1) Extend recruitment at all 8 LEO centers, with a goal of recruiting 3400 newly diagnosed NHL patients focused on Hispanic (N=900), African American (N=580), and Asian (N=200) participants (doubling the current sample size for these groups) and adolescent and young adult (AYA) participants age 18-39 years (N=870; 87% increase), and non-metro and rural patients of all ages and race/ethnicities (N=1,208, 72% increase), for a total cohort of 16,500 patients; 2) Review all pathology diagnoses and maintain a NHL tumor bank that includes an H&E slide, formalin-fixed, paraffin-embedded tissue samples in a tissue microarray, and extracted tumor DNA and RNA; 3) Collect a peripheral blood sample and maintain a central biorepository of DNA, serum, plasma and buffy coat; 4) Annotate and harmonize all cases with clinical, epidemiologic, pathology and treatment data, including development of new informatics enhancements to capture clinical data from electronic health records, digital pathology images and linkage to public databases to enhance data on environmental exposures and socioeconomic factors; 5) Prospectively follow patients in the cohort to ascertain disease progression/relapse, retreatment, transformation, second cancers, survival (including cause of death), updated exposures, patient- reported outcomes (PROs), and other long-term health outcomes; and 6) Facilitate research projects that use this infrastructure, promote interactions with NCI-supported clinical trials networks, patient advocacy groups, and other collaborators. We will achieve these aims through close coordination of each of the participating centers, supported by four cores (Administration; Clinical; Pathology & Biospecimens; and Biostatistics & Informatics). The LEO cohort is an exceptional resource that supports a broad research agenda aimed at identifying novel clinical, epidemiologic, germline genetic, tumor, and treatment factors that influence NHL prognosis and survivorship focusing on NCI research priorities in AYA, minority, and rural populations. LEO is led by international experts in clinical and epidemiologic research on NHL, thereby driving the translation of new findings to the clinic and the population.