Clinical registry Core

临床注册核心

基本信息

批准号：
8234104
负责人：
RANDALL Walter BURT
金额：
$ 38.82万
依托单位：
UNIVERSITY OF UTAH
依托单位国家：
美国
项目类别：
财政年份：
2011
资助国家：
美国
起止时间：
2011-03-01 至 2015-02-28
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8234104
关键词：
Adenomatous Polyposis Coli Archives Basic Science Blood specimen Budgets Caring Clinic Clinical Clinical Investigator Clinical Sciences Clinical Trials Collection Colon Carcinoma Colonic Polyps Colonoscopy Communities Computer software Computers Confidentiality Core Facility Data Data Analyses Databases Development Plans Dissection Education Electronics Endoscopy Enrollment Epidemiology Family Family Cancer History Family history of Family member Funding Genealogy Genetic Genetic Counseling Genetic screening method Hereditary Malignant Neoplasm High-Risk Cancer Housing Human Idaho Individual Information Systems Informed Consent Inherited Institutes Investigation Laboratory Finding Link Mails Maintenance Maintenance Therapy Malignant Neoplasms Medical Medical Genetics Medical History Medical Records Molecular Molecular Genetics Normal tissue morphology Notification Nurses Pathway interactions Patient Care Patients Persons Physicians Polyps Population Database Process Professional counselor Recording of previous events Records Registries Research Research Infrastructure Research Personnel Research Subjects Resources Risk Sampling Scientist Screening for cancer Screening procedure Secure Sigmoidoscopy Syndrome Systems Biology Telephone Testing Time Tissue Sample Universities Utah Vital Statistics anticancer research cancer diagnosis clinical care cohort computerized data management disorder prevention follow-up gene discovery high risk improved inhibitor/antagonist kindred member neoplasm registry patient registry peer programs repository sample collection tissue resource treatment program tumor progression

项目摘要

The Clinical Coordination Core (Core C) provides a comprehensive long-term resource for clinical and basic investigation as well as clinical care for persons and families with inherited risk of colon cancer. Core C coordinates the Familial Colon Cancer Registry, the Colon Cancer Research Clinics, the Subject Database, the genealogies and vital statistics of the Utah Population Database, the Utah and Idaho Cancer Registries, and the Tissue Resource and Applications Core Facility to form a cohesive, accessible, repository of information. The clinics coordinated by this core are staffed by physician-scientists, nurses, coordinators, genetic counselors, and computer professionals. Activities of this core include: mail and telephone subject contact, study registration, administration of informed consent, demographic, epidemiological, medical history and family cancer history data gathering, blood and tissue sampling, and clinical care. Clinical care includes education; genetic counseling and testing; cancer screening; colonoscopy for polyp and cancer diagnosis, referral for treatment, and continuation of care; upper Gl endoscopy as indicated; and appropriate patient follow-up. Long-term participation is accomplished through the registry, which tracks patients and sends educational information, and notification for possible enrollment in studies. The Registry enrolls family members of those with inherited syndromes as well as members with less well-defined familial colon cancer. Computerized data management permits storage and queries of medical and family history information; tracking of patient interactions, genetic, and molecular testing information; and blood and tissue sampling (encompassing acquisition, processing, storage, tracking and distribution). All data systems and information are secured. Core C will serve as a referral resource for patients to the clinical trial of Project 1, which will assess which pathways known to be involved in colon cancer progression are suppressed by the use of COX and EFGR inhibitors. Deidentified adenomatous and normal tissue samples will be collected in Project 1, archived in the Tissue Resource and Applications Core Facility, and linked to medical, genetic, and family history records in the Subject Database for use in data analysis. Biospecimens from these same kindreds, expanded through family expansion and the use of the Utah Population Database, will be used by the other projects, to augment their systems biology approach to pathway dissection of tumor progression.

临床协调核心（Core C）为临床和基础研究提供了全面的长期资源，以及针对患有结肠癌风险的人和家庭的临床护理。核心C协调家族性结肠癌注册中心，结肠癌研究诊所，受试者数据库，犹他州人口数据库的家谱和重要统计数据，犹他州和爱达荷州癌症的注册表以及组织资源和应用核心设施，以形成一个凝聚力，可访问，可访问的信息。该核心协调的诊所由医师科学家，护士，协调员，遗传顾问和计算机专业人士组成。该核心的活动包括：邮件和电话主题联系，学习注册，知情同意，人口统计学，流行病学，病史和家庭癌症史数据收集，血液和组织采样以及临床护理。临床护理包括教育；遗传咨询和测试；癌症筛查；用于息肉和癌症诊断的结肠镜检查，用于治疗的转诊和持续护理；上GL内窥镜检查如图所示；和适当的患者随访。长期参与是通过注册表来完成的，该注册表跟踪患者并发送教育信息，并通知可能入学研究。该注册表招募了遗传综合症的家庭成员以及定义不太定义的家族性结肠癌的成员。计算机数据管理允许对医学和家族史信息的存储和查询；跟踪患者相互作用，遗传和分子测试信息；以及血液和组织采样（包括采集，加工，存储，跟踪和分布）。所有数据系统和信息均得到保护。 Core C将作为项目1的临床试验的患者的推荐资源，该试验将通过使用COX和EFGR抑制剂来抑制已知参与结肠癌进展的途径。将在项目1中收集了已鉴定的腺瘤和正常组织样本，在组织资源和应用中存档，并与该受试者数据库中的医学，遗传和家族史记录有关，以用于数据分析。通过家庭扩张和犹他州人口数据库的使用，来自这些相同亲属的生物测量将被其他项目使用，以扩大其系统生物学方法来解剖肿瘤进展的途径。