Clinical Core

临床核心

基本信息

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
项目类别：
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

项目摘要

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) 的中心任务是监督临床研究开发的各个方面、患者 CC 的科学项目的招募和样本收集由 Paul 博士领导。 Bunn、Philip Mack 和 Jorge Gomez 以及共同研究员 Brody 博士（西奈山癌症中心主任）。 Biorepository）以及 Henschke 和 Yankelevitz 博士（西奈山肺癌筛查主任）网络），CC在临床试验开发、转化医学和如目标 1 中所述，CC 将负责开发、合规性、 IRB 批准、实施和监测作为该 U54 中心基础的临床研究。 CC 的首要责任是严格维护所有监管、安全、隐私、保密和利用临床研究注册所需的合规要素。在西奈山蒂施癌症研究所临床试验办公室，CC 将监督所有研究注册，如下所有 HIPAA 和监管合规要素均由 CC 开发和管理，该研究将由 CC 进行开发和管理。与数据科学核心和项目研究人员密切合作，在指导下实施在目标 2 中，CC 将识别并登记肺癌和癌症。将对照受试者纳入研究，收集所需的纵向临床信息和连续血液肺癌患者的样本主要来自西奈山，一些特别感兴趣的患者。（年轻、少数族裔）将通过 GO2 肺癌基金会网络招募。匹配的对照将从西奈山肺癌筛查计划中招募，并将由过去 5 年内没有肺癌证据且没有活动性癌症的个体（皮肤癌除外），随着疫苗的出现，招募将与年龄、性别、种族和吸烟史相匹配。从研究对 SARS-CoV-2 自然感染的抗体反应转向疫苗诱导的抗体目标 3 涉及高质量响应的收集、处理、存储、编码和交付。将前瞻性地从所有研究参与者那里采集血液样本。 CC 将作为项目之间的渠道。和数据科学核心，提供符合 HIPAA 标准的数据和样本，这些数据和样本已匿名提供给项目研究人员将利用蒂施癌症中心的现有基础设施进行检测。研究所的生物存储库，维护自己的分区、密码保护的数据库和专用的、良好的数据库受监控的冷冻空间。