The Lymphoma Epidemiology of Outcomes (LEO) Cohort Study

淋巴瘤流行病学结果 (LEO) 队列研究

基本信息

批准号：
10593053
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
项目类别：
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/10593053
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 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&apos 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 Survivors Tissue Microarray Tissue Sample Translations Treatment Factor Tumor Bank Update Validation biobank clinical practice cohort design digital imaging digital pathology epidemiologic data epidemiology study follow-up improved insight non-Hodgkin&apos 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

项目摘要

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.

项目概要 2020 年，美国估计将有 77,240 人被诊断出患有非霍奇金淋巴瘤 (NHL)，并且 19,940 人将死于这种癌症。 NHL 发病率在 20 世纪后半叶有所增加，并且仅最近稳定下来。与此同时，随着 20 世纪 90 年代中期 NHL 的出现，NHL 的存活率开始提高。改进的治疗策略，导致目前的 5 年生存率为 74%。这些趋势导致了 NHL 幸存者人数增长，2019 年估计超过 757,000 人。解决未满足的健康问题为了满足该患者群体的需求，我们建立了淋巴瘤流行病学结果 (LEO) 队列研究，到 2020 年 6 月，该项目将招募超过 13,000 名 NHL 患者，失访率<1%。低地轨道该队列支持多项资助，并在 NHL 预后和治疗方面产生了新颖且具有重大影响的发现生存。为了继续并扩大 LEO 的关键贡献，在本次更新中，我们建议： 1) 延长在所有 8 个 LEO 中心进行招募，目标是招募 3400 名新诊断的 NHL 患者，重点关注西班牙裔 (N=900)、非裔美国人 (N=580) 和亚洲人 (N=200) 参与者（将当前样本增加一倍）这些群体的规模）以及年龄 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/民族的非都市和农村患者（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 H&E 载玻片、福尔马林固定、石蜡包埋的组织样本置于组织微阵列中，并提取肿瘤 DNA 和RNA； 3) 收集外周血样本并维护 DNA、血清、血浆的中央生物储存库和血沉棕黄层； 4) 对所有病例进行临床、流行病学、病理学和治疗数据的注释和协调，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，数字病理学图像以及与公共数据库的链接，以增强有关环境暴露和风险的数据社会经济因素； 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、生存（包括死亡原因）、更新的暴露、患者- 报告结果 (PRO) 和其他长期健康结果； 6) 促进使用的研究项目该基础设施，促进与 NCI 支持的临床试验网络、患者倡导团体的互动，和其他合作者。我们将通过每个参与方的密切协调来实现这些目标中心，由四个核心支持（管理；临床；病理学和生物样本；以及生物统计和信息学）。 LEO 群体是一个特殊的资源，支持广泛的研究议程，旨在识别影响 NHL 的新临床、流行病学、种系遗传、肿瘤和治疗因素预后和生存率重点关注 NCI 在 AYA、少数民族和农村人口中的研究重点。低地球轨道是由国际专家领导的 NHL 临床和流行病学研究，从而推动了 NHL 的转化诊所和人群的新发现。