Clinical Core

临床核心

• 批准号: 10688375
• 负责人: PHILIP C MACK
• 金额: $ 39.72万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-30 至 2024-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10688375
• 关键词: 2019-nCoV; Address; Adopted; Advisory Committees; Age; Antibodies; Antibody Response; Biological Assay; Blinded; Blood; Blood specimen; COVID-19 risk; Cancer Control; Cancer Patient; Clinical; Clinical Research; Clinical Trials; Collection; Colorado; Comprehensive Cancer Center; Control Groups; Data; Data Science Core; Databases; Development; Doctor of Philosophy; Elements; Enrollment; Ethnic Origin; Foundations; Freezing; Gender; Health Insurance Portability and Accountability Act; Human; Individual; Infection; Infrastructure; Institutes; Institution; Institutional Review Boards; Leadership; Lung; Malignant Neoplasms; Malignant neoplasm of lung; Medical Oncology; Medical center; Minority Groups; Mission; Molecular; Monitor; Mutation; Names; Participant; Pathology; Patient Recruitments; Patients; Pharmaceutical Preparations; Pharmacology Shared Resource; Population Control; Privacy; Process; Publications; Reporting; Research; Research Personnel; Resources; Role; SARS-CoV-2 infection; Safety; Sampling; Science; Serology; Site; Skin Cancer; Smoking History; Southwest Oncology Group; Specimen; System; Thoracic Oncology; Tobacco smoking behavior; Translational Research; Underserved Population; Universities; Ursidae Family; Vaccines; Work; anticancer research; base; biobank; design; distinguished professor; experience; interest; low dose computed tomography; lung cancer screening; minority children; operation; professor; programs; prospective; protocol development; recruit; routine screening; sample collection; screening program; translational medicine; translational scientist; vaccine-induced antibodies

CLINICAL CORE: ABSTRACT The central mission of the Clinical Core (CC) is to oversee all aspects of clinical study development, patient recruitment and specimen collection for analysis in the Center’s scientific projects. The CC is led by Drs. Paul Bunn, Philip Mack, and Jorge Gomez. Together with co-investigators Dr. Brody (Director of Mount Sinai Cancer Biorepository) and Drs. Henschke and Yankelevitz (Directors of the Mount Sinai Lung Cancer Screening Network), the CC brings to bear a wealth of experience in clinical trials development, translational medicine and biorepository management. As described in Aim 1, the CC will be responsible for development, compliance, IRB-approval, implementation and monitoring of the clinical study that serves as the basis for this U54 Center. A foremost responsibility of the CC will be to rigorously maintain all regulatory, safety, privacy, confidentiality and compliance elements necessary for clinical study enrollment. Leveraging the experience and infrastructure of the Mount Sinai Tisch Cancer Institute Clinical Trials Office, the CC will oversee all study enrollment, following all HIPAA and regulatory compliance elements. While developed and managed by the CC, the study will be implemented in close partnership with the Data Science Core, and Project Investigators, under the guidance of the Center leadership and Steering Committee. In Aim 2, the CC will Identify and enroll lung cancer and control subjects onto the study, collecting the required longitudinal clinical information and serial blood specimens. Lung cancer patients will be recruited mostly from Mount Sinai. Some patients of special interest (younger, minorities) will be recruited through the GO2 Foundation for Lung Cancer network. Non-lung cancer matched controls will be recruited from the Mount Sinai Lung Cancer Screening Program, and will be composed of individuals with no evidence of lung cancer and no active cancer within the last 5 years (except skin cancer), matched by age, gender, ethnicity and tobacco smoking history. As vaccines become available, recruitment will segue from studying antibody response to natural infection with SARS-CoV-2 to vaccine-induced antibodies responses. Aim 3 addresses the collection, processing, storage, encoding and delivery of high-quality specimens to Project Investigators. From all study participants, blood specimens will be collected prospectively at baseline, and 3, 6, 12 and 24 month following enrollment. The CC will serve as a conduit between the Projects and the Data Science Core by providing HIPAA-compliant data and samples that have been anonymized to the project investigators conducting assays. The CC will utilize the existing infrastructure of the Tisch Cancer Institute’s Biorepository, maintaining its own partitioned, password-protected database and dedicated, well- monitored freezer space.

临床核心：摘要 临床核心（CC）的核心任务是监督临床研究开发的各个方面 招聘和标本收集，以在中心的科学项目中进行分析。 CC由Drs领导。保罗 Bunn，Philip Mack和Jorge Gomez。与共同研究员布罗迪博士（西奈山山山的主任 生物座席）和博士。 Henschke和Yankelevitz（西奈山肺癌筛查的董事 网络），CC在临床试验开发，转化医学和 生物验证管理。如AIM 1所述，CC将负责开发，合规性， IRB批准，对临床研究的实施和监测，这是该U54中心的基础。 CC最重要的责任是严格维护所有监管，安全，隐私，机密性和 临床研究入学所必需的合规性要素。利用 西奈山tisch癌研究所临床试验办公室，CC将监督所有研究入学率 所有HIPAA和法规合规性要素。在由CC开发和管理的同时，该研究将是 与数据科学核心和项目调查人员密切合作，在该指导下实施 中心领导和指导委员会。在AIM 2中，CC将识别和招募肺癌和 控制受试者到研究中，收集所需的纵向临床信息和串行血液 规格。肺癌患者将主要从西奈山招募。一些特别感兴趣的患者 （年轻，少数民族）将通过GO2肺癌网络招募。非肺癌 匹配的控件将从西奈山肺癌筛查计划中招募，并将组成 在过去的5年内没有肺癌证据和没有活性癌的人（皮肤癌除外）， 按年龄，性别，种族和烟草吸烟史进行匹配。随着疫苗的可用，招募将 从研究对自然感染的抗体反应SARS-COV-2对疫苗诱导的抗体的反应 回答。 AIM 3解决了高质量的集合，处理，存储，编码和交付 项目调查人员的标本。在所有研究参与者中，将预先收集血液标本 入学后的基线和3、6、12和24个月。 CC将用作项目之间的管道 以及数据科学核心通过提供符合HIPAA的数据和已匿名化的样本 进行阿萨斯的项目调查人员。 CC将利用Tisch Cancer的现有基础设施 研究所的生物座位，维护自己的分区，受密码保护的数据库和专用，良好的 受监控的冰柜空间。