The Lymphoma Epidemiology of Outcomes (LEO) Cohort Study

淋巴瘤流行病学结果 (LEO) 队列研究

• 批准号: 10381614
• 负责人: JAMES R CERHAN
• 金额: $ 193.81万
• 依托单位: MAYO CLINIC ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-06-23 至 2026-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10381614
• 关键词: Address; Adolescent and Young Adult; African American; African American population; Age; Asian; Automobile Driving; Biological; Biometry; Blood specimen; Cause of Death; Clinic; Clinical; Clinical Data; Clinical Pathology; Clinical Research; Clinical Trials; Clinical Trials Network; Cohort Studies; DNA; Data; Data Collection; Development; Diagnosis; Disease Progression; Electronic Health Record; Enrollment; Environmental Exposure; Epidemiology; Ethnic Origin; Formalin; Fostering; Foundations; Funding; General Population; Genetic; Goals; Grant; Growth; Health; Hematologic Neoplasms; Hispanic; Incidence; Industry; Informatics; Infrastructure; International; K-Series Research Career Programs; Knowledge; Life Style; Lymphoma; Malignant Neoplasms; Minority Groups; Newly Diagnosed; Non-Hodgkin' s Lymphoma; Outcome; Paraffin Embedding; Participant; Pathology; Patient Outcomes Assessments; Patients; Personal Satisfaction; Persons; Plasma; Population; Prognosis; Provider; Public Health; Publications; RNA; Race; Relapse; Research; Research Methodology; Research Personnel; Research Priority; Research Project Grants; Resources; Retreatment; Risk; Rural Population; Sample Size; Science; Second Primary Cancers; Serum; Site; Slide; Socioeconomic Factors; Specimen; Statistical Models; Survival Rate; Tissue Microarray; Tissue Sample; Translations; Treatment Factor; Tumor Bank; Update; Validation; base; biobank; cancer survival; clinical practice; cohort; design; digital pathology; epidemiologic data; epidemiology study; follow-up; improved; insight; non-Hodgkin' s lymphoma patients; novel; novel strategies; pathology imaging; patient advocacy group; patient population; peripheral blood; prospective; public database; radiological imaging; recruit; residence; risk stratification; rural patients; survivorship; treatment strategy; trend; tumor; tumor DNA

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.

项目摘要 到2020年，美国估计将有77，240人被诊断患有非霍奇金淋巴瘤（NHL）， 19，940人将死于这种癌症。NHL发病率在世纪后半叶增加， 最近稳定下来。与此同时，NHL的生存率在20世纪90年代中期开始改善， 改善治疗策略，使目前的5年生存率达到74%。这些趋势导致了 NHL幸存者人数的增长，估计在2019年超过757，000人。解决未得到满足的健康问题 为了满足这一患者人群的需求，我们建立了淋巴瘤流行病学结局（LEO）队列研究， 到2020年6月，将招募超过13，000名NHL患者，失访率<1%。狮子座 队列支持多项赠款，并对NHL预后产生了新的和高影响的发现， 生存。为了继续和扩大低地轨道组织的主要贡献，在这次更新中，我们建议：1）扩大 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）受试者（当前样本加倍 这些群体的规模）和青少年和年轻成人（AYA）参与者年龄18-39岁（N=870; 87% 增加），以及所有年龄和人种/种族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， H&E载玻片，福尔马林固定，石蜡包埋的组织样品在组织微阵列中，并提取肿瘤DNA 3）收集外周血样品，并维持DNA、血清、血浆的中央生物储存库 和血沉棕黄层; 4）注释并协调所有病例与临床、流行病学、病理学和治疗数据， 包括开发新的信息学增强功能，以从电子健康记录中获取临床数据， 数字病理学图像和与公共数据库的连接，以增强环境暴露数据， 社会经济因素; 5）Proximity跟踪队列中的患者以确定疾病进展/复发， 再治疗、转化、第二种癌症、生存率（包括死亡原因）、更新的暴露量、患者- 报告的结果（PRO）和其他长期健康结果;以及6）促进使用 这一基础设施，促进与国家癌症研究所支持的临床试验网络，病人倡导团体， 和其他合作者。我们将通过各参与方的密切协调来实现这些目标。 中心，由四个核心（行政;临床;病理学和生物标本;和生物统计学和 信息学）。低地球轨道队列是一种特殊的资源，支持广泛的研究议程，旨在 确定影响NHL的新的临床、流行病学、生殖系遗传、肿瘤和治疗因素 预后和生存的重点是NCI的研究重点在AYA，少数民族和农村人口。狮子座是 由NHL临床和流行病学研究的国际专家领导，从而推动了 新的发现对临床和人群。