Clinical registry Core

临床注册核心

基本信息

批准号：
8449518
负责人：
RANDALL Walter BURT
金额：
$ 35.92万
依托单位：
UNIVERSITY OF UTAH
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-03-01 至 2015-02-28
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8449518
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 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 screening 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（核心 C）为临床和基础研究以及具有结肠癌遗传风险的个人和家庭的临床护理提供全面的长期资源。核心 C 协调家族结肠癌登记处、结肠癌研究诊所、受试者数据库、犹他州人口数据库的谱系和生命统计、犹他州和爱达荷州癌症登记处以及组织资源和应用核心设施，以形成一个有凝聚力的、可访问的信息存储库。由该核心协调的诊所由医师科学家、护士、协调员、遗传咨询师和计算机专业人员组成。该核心的活动包括：邮件和电话联系受试者、研究注册、知情同意管理、人口统计、流行病学、病史和家族癌症史数据收集、血液和组织采样以及临床护理。临床护理包括教育；遗传咨询和检测；癌症筛查；用于息肉和癌症诊断、转诊治疗和持续护理的结肠镜检查；上消化道内窥镜检查如所示；以及适当的患者随访。长期参与是通过登记来完成的，该登记跟踪患者并发送教育信息以及可能参加研究的通知。该登记处招募患有遗传综合征的家庭成员以及患有不太明确的家族性结肠癌的成员。计算机化数据管理允许存储和查询医疗和家族史信息；跟踪患者互动、遗传和分子检测信息；血液和组织采样（包括采集、处理、存储、跟踪和分发）。所有数据系统和信息均受到保护。 Core C 将作为项目 1 临床试验患者的转介资源，该试验将评估哪些已知参与结肠癌进展的途径通过使用 COX 和 EFGR 抑制剂而受到抑制。项目 1 将收集去识别的腺瘤和正常组织样本，存档在组织资源和应用核心设施中，并与受试者数据库中的医学、遗传和家族史记录相链接，用于数据分析。来自这些相同家族的生物样本，通过家族扩张和犹他州人口数据库的使用而扩大，将被其他项目使用，以增强他们的系统生物学方法来解析肿瘤进展的途径。