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: 9379101
• 负责人: JAMES R CERHAN
• 金额: $ 1.5万
• 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/9379101
• 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 Pathology; Clinical Research; Clinical Trials; Clinical Trials Network; Cohort Studies; DNA; DNA Library; Data; Data Collection; Databases; Diagnosis; Diffuse; Disease; Disease Progression; Epidemiology; Etiology; Follicular Lymphoma; Formalin; Fostering; Funding; Genetic; Goals; Grant; Growth; Health; Hematologic Neoplasms; 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; Plasma; Population; Protocols documentation; Public Health; RNA; Recruitment Activity; Relapse; Research; Research Design; Research Infrastructure; Research Methodology; Research Personnel; Research Project Grants; Resources; Retreatment; Risk stratification; Sampling; Science; Second Primary Cancers; Serum; 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; epidemiology study; follow-up; improved; improved outcome; insight; novel; novel strategies; outcome forecast; patient population; peripheral blood; prognostic; prospective; public health relevance; secondary analysis; survivorship; treatment strategy; 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（由申请人提供）：2014年，美国估计有70，800人将被诊断患有非霍奇金淋巴瘤（NHL），18，990人将死于这种癌症。NHL的发病率在世纪后半叶增加，直到最近才稳定下来。与此同时，NHL的生存率在20世纪90年代中期随着治疗策略的改进而开始改善，导致目前的5年生存率为69%。这些趋势导致非霍奇金淋巴瘤幸存者人数增加，估计2010年超过650，000人。为了解决这一不断增长的患者群体的当前和长期未满足的健康需求，我们建议建立淋巴瘤流行病学结局（LEO）队列研究，该研究将扩大2002年建立的4，000多名NHL患者的正在进行的队列。将这一基础设施扩大到12，000多名NHL患者的目标是支持广泛的研究议程，旨在确定新的临床，流行病学，宿主遗传，肿瘤和治疗因素，这些因素会显著影响NHL预后和生存率。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个新中心，目标是招募8，700名新诊断的NHL患者（包括1，000名非洲裔美国人和1，400名西班牙裔参与者），共12，900名患者（包括3，700例弥漫性大B细胞淋巴瘤和3，30例滤泡性淋巴瘤）; 2）审查所有病理诊断并建立NHL肿瘤库，其包括H&E载玻片、福尔马林固定的石蜡包埋的组织样品以及提取的肿瘤DNA和RNA; 3）收集外周血样品和DNA库、血清、血浆和血沉棕黄层在中央生物储存库中; 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; 5）普罗维登定期随访队列中的患者，以确定疾病进展/复发、再治疗、转化、第二种癌症、存活率（包括死亡原因），更新的暴露，患者报告的结果（PRO）和其他长期健康结果;以及6）促进使用此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（管理;临床;病理学和生物标本;生物统计学和信息学）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、生物标本科学和统计建模。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，并将用于改善NHL患者的诊断、风险分层、治疗以及短期和长期管理。LEO研究人员将利用这一资源来促进新的生物学和临床见解的发现和验证。LEO将由NHL临床和流行病学研究的国际领导者领导，从而推动新发现向临床和人群的转化。