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：
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
项目类别：
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&apos 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

项目摘要

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，美国估计将有 70,800 人被诊断出患有非霍奇金淋巴瘤 (NHL)，并且 18,990 人将死于这种癌症，并且这种癌症的发病率在 20 世纪下半叶有所增加。与此同时，随着治疗策略的改进，NHL 的生存率在 20 世纪 90 年代中期开始提高，导致目前的 5 年生存率下降。这些趋势导致 NHL 幸存者人数增加，2010 年估计超过 650,000 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，该研究将扩大 2002 年建立的由 4,000 多名 NHL 患者组成的持续队列。目标是将这一基础设施扩展到超过12,000 名 NHL 患者将支持一项广泛的研究议程，旨在确定显着影响 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)将招募范围扩大到六个新中心，目标是招募 8,700 名新诊断的 NHL 患者（包括 1,000 名非裔美国人和 1,400 名西班牙裔参与者），总共队列12,900 名患者（包括 3,700 名弥漫性大 B 细胞和 3,30 名滤泡性淋巴瘤）；2) 审查所有病理诊断并建立 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和提取的肿瘤DNA 和 RNA；3) 收集外周血样本并将 DNA、血清、血浆和血沉棕黄层存入中央生物样本库 4) 注释和使所有病例与临床、流行病学、病理学和治疗数据相一致；5) 定期定期随访队列中的患者，以确定疾病进展/复发、再治疗、转化、第二癌症、生存率（包括死亡原因）、更新的暴露情况、患者报告成果（PRO）和其他长期健康成果；6）促进利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。由四个核心（管理；临床；病理学和生物样本；以及生物统计和信息学）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、生物样本科学和统计建模。 LEO 研究人员将利用这一资源来促进新型药物的发现和验证。 LEO 将由 NHL 临床和流行病学研究领域的国际领导者领导，从而推动新发现向临床和人群的转化。