Clinical registry Core

临床注册核心

• 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
• 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

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了全面的长期资源。核心C协调家族性结肠癌登记处、结肠癌研究诊所、受试者数据库、犹他州人口数据库的家谱和生命统计数据、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、可访问的信息库。 由该中心协调的诊所由医生-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、研究登记、知情同意书的管理、人口统计学、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的结肠镜检查、转诊治疗和继续护理;如所示的上GI内窥镜检查;以及适当的患者随访。长期参与是通过登记完成的，登记跟踪患者并发送教育信息，以及可能入组研究的通知。该登记处招募了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;以及血液和组织采样（包括采集、处理、存储、跟踪和分配）。所有数据系统和信息都是安全的。 核心C将作为患者参与项目1临床试验的转诊资源，该临床试验将评估使用考克斯和EFGR抑制剂抑制已知参与结肠癌进展的途径。将在项目1中采集无法识别的腺瘤和正常组织样本，在组织资源和应用核心机构中存档，并与受试者数据库中的医疗、遗传和家族史记录相关联，用于数据分析。通过家族扩展和使用犹他州人口数据库扩展的来自这些相同激酶的生物标本将被其他项目使用，以增强其系统生物学方法来进行肿瘤进展的通路解剖。