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: 9334403
• 负责人: JAMES R CERHAN
• 金额: $ 4.53万
• 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 2020-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9334403
• 关键词: Address; African American; Automobile Driving; B-Lymphocytes; Biometry; Blood Banks; Blood specimen; Cancer Center; Cause of Death; Cells; Clinic; Clinical; Clinical Data; Clinical Research; Clinical Trials; Clinical Trials Network; Cohort Studies; DNA; Data; Data Collection; Databases; Diagnosis; Diffuse; Disease; Disease Progression; Epidemiologic Studies; Epidemiology; Follicular Lymphoma; Formalin; Fostering; Funding; Genetic; Goals; Grant; Growth; Health; Hematologic Neoplasms; Hematoxylin and Eosin Staining Method; Hispanics; Incidence; Informatics; Institution; International; Iowa; Knowledge; Life Style; Lymphoma; Malignant Neoplasms; Molecular Epidemiology; Newly Diagnosed; Non-Hodgkin' s Lymphoma; Outcome; Paraffin Embedding; Participant; Pathology; Patient Outcomes Assessments; Patients; Personal Satisfaction; Plasma; Population; Protocols documentation; Public Health; RNA; Recruitment Activity; Relapse; Research; Research Design; Research Infrastructure; Research Personnel; Research Project Grants; Resources; Retreatment; Risk; Sampling; Science; Second Primary Cancers; Slide; Specialized Program of Research Excellence; Specimen; Statistical Models; Survival Rate; Survivors; TNFRSF5 gene; Tissue Microarray; Tissue Sample; Translations; Treatment Factor; Tumor Bank; Tumor Tissue; Universities; Update; Validation; biobank; cancer survival; case control; clinical epidemiology; clinical practice; cohort; design; epidemiologic data; follow-up; improved; improved outcome; insight; meetings; novel; novel strategies; outcome forecast; patient population; peripheral blood; public health relevance; survivorship; treatment strategy; treatment stratification; trend; tumor; tumor DNA

 DESCRIPTION (provided by applicant): In 2014, an estimated 70,800 people in the US will be diagnosed with non-Hodgkin lymphoma (NHL), and 18,990 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 69 percent. These trends have led to a growth in the number of NHL survivors, estimated at over 650,000 in 2010. To address the current and long-term unmet health needs of this growing patient population, we propose to establish the Lymphoma Epidemiology of Outcomes (LEO) cohort study, which will expand an ongoing cohort of over 4,000 NHL patients that was established in 2002. The goal of expanding this infrastructure to over 12,000 NHL patients is to support a broad research agenda aimed at identifying novel clinical, epidemiologic, host genetic, tumor, and treatment factors that significantly influence NHL prognosis and survivorship. To meet these goals, over the next 5 years we propose to: 1) Expand recruitment to six new centers, with a goal of recruiting 8,700 newly diagnosed NHL patients (including 1,000 African American and 1,400 Hispanic participants), for a total cohort of 12,900 patients (including 3,700 diffuse large B-cell and 3,30 follicular lymphomas); 2) Review all pathology diagnoses and build a NHL tumor bank that includes an H&E slide, a formalin-fixed, paraffin-embedded tissue samples, and extracted tumor DNA and RNA; 3) Collect a peripheral blood sample and bank DNA, serum, plasma and buffy coat in a central biorepository; 4) Annotate and harmonize all cases with clinical, epidemiologic, pathology and treatment data; 5) Prospectively follow patients in the cohort regularly 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 and promote interactions with lymphoma clinical trial networks. 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). These cores will also conduct methodological research to enhance data collection, patient follow-up, biospecimen science and statistical modeling. The proposed LEO cohort infrastructure overcomes limitations of other study designs, is feasible, and will be used to improve diagnosis, risk stratification, treatment, and short and long-term management of NHL patients. The LEO investigators will leverage this resource to foster discovery and validation of novel biologic and clinical insights. LEO will be led by international leaders in clinical and epidemiologic research on NHL thereby driving the translation of new findings to the clinic and the population.

 描述(申请人提供)：2014年，美国估计将有70,800人被诊断为非霍奇金淋巴瘤(NHL)，其中18,990人将死于这种癌症。非霍奇金淋巴瘤的发病率在20世纪后半叶有所上升，直到最近才稳定下来。与此同时，随着改进的治疗策略的出现，非霍奇金淋巴瘤的存活率在20世纪90年代中期开始改善，导致目前的5年存活率为69%。这些趋势导致非霍奇金淋巴瘤幸存者的数量增加，2010年估计超过650000人。为了解决这一不断增长的患者群体当前和长期未得到满足的健康需求，我们建议建立淋巴瘤流行病学结果(LEO)队列研究，这将扩大2002年建立的4000多名NHL患者的持续队列。将这一基础设施扩展到12,000多名NHL患者的目标是支持广泛的研究议程，旨在确定显著影响NHL预后和生存的新的临床、流行病学、宿主遗传、肿瘤和治疗因素。为了实现这些目标，我们建议在未来5年内：1)将招募范围扩大到6个新的中心，目标是招募8,700名新诊断的NHL患者(包括1,000名非裔美国人和1,400名西班牙裔参与者)，总共12,900名患者(包括3,700名弥漫性大B细胞淋巴瘤和3，30名滤泡性淋巴瘤)；2)审查所有病理诊断，建立包括H&E玻片、福尔马林固定的石蜡包埋组织样本和提取的肿瘤DNA和RNA的NHL肿瘤库；3)收集外周血样和中心生物储存库中的DNA、血清、血浆和黄褐色涂层；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；5)定期跟踪队列中的患者，以确定疾病进展/复发、再治疗、转化、第二癌症、生存(包括死因)、最新暴露情况、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的研究项目，并促进与淋巴瘤临床试验网络的互动。我们将通过每个参与中心的密切协调来实现这些目标，并由四个核心(行政、临床、病理学和生物显微镜以及生物统计和信息学)提供支持。这些核心还将进行方法学研究，以加强数据收集、患者随访、生物显微镜科学和统计建模。拟议的LEO队列基础设施克服了其他研究设计的局限性，是可行的，将用于改善NHL患者的诊断、风险分层、治疗以及短期和长期管理。利奥研究人员将利用这一资源来促进对新的生物和临床见解的发现和验证。LEO将由非霍奇金淋巴瘤临床和流行病学研究的国际领导者领导，从而推动将新发现转化为临床和人口。