Clinical Trials

临床试验

• 批准号: 7245712
• 负责人: MACE L ROTHENBERG
• 金额: $ 15.27万
• 依托单位: VANDERBILT UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-05-01 至 2012-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7245712
• 关键词: Adherence; Biology; Biopsy; Clinical; Clinical Trials; Collaborations; Colorectal Cancer; Colorectal Polyp; Conduct Clinical Trials; Data; Data Collection; Databases; Development; E-Cadherin; Eastern Cooperative Oncology Group; Enrollment; Epidemiologic Studies; Epidermal Growth Factor Receptor; Goals; Grant; Knowledge; Lead; Malignant Neoplasms; Malignant neoplasm of gastrointestinal tract; Metastatic Neoplasm to the Liver; Monitor; Nature; Neoadjuvant Therapy; Nursing Research; Patients; Protocols documentation; Reproduction spores; Research Subjects; Resectable; Risk; Safety; Specific qualifier value; Specimen; System; Tennessee; Therapeutic Clinical Trial; Translational Research; computerized; data management; design; follow-up; improved; insight; kinase inhibitor; src-Family Kinases; translational clinical trial; tumor

The Clinical Trials Core will provide expertise in the development, implementation and coordination of the clinical translational research trials performed in the Gl SPORE. The ultimate goal is to develop improved therapies for patients with or at risk of developing gastrointestinal cancers through a better understanding of the biology of those cancers. To achieve this goal, the major responsibilities of the Clinical Trials Core will be to 1) provide expertise in the development and implementation of translational clinical trials related to the SPORE projects; 2) assure and maintain adequate accrual of patients to participate in SPORE-initiated trials; 3) provide research nurse, data manager; and specimen procurement support for these clinical trials; 4) monitor and assure the safety of research subjects, adherence to institutional and federal regulatory requirements, and compliance with protocol-specified activities; and 5) overseethe timely and accurate entry of data into the OnCore database. During the previous grant period, the Clinical Trials Core provided support for four therapeutic clinical trials that accrued 65 study patients at Vanderbilt and 142 patients overall, and one epidemiologic study, the Tennessee Colorectal Polyp Study, which enrolled 3744 patients. The core's efforts were pivotal in coordinating a study performed in conjunction with the Eastern Cooperative Oncology Group in which paired tumor biopsies were obtained from 25% of patients enrolled group-wide and in 18 of 19 (95%) patients enrolled at Vanderbilt. In the competing renewal, the Clinical Trials Core will support trials included in Project 1 including combined blockade of the EGFR axis in patients with advanced colorectal cancer during Years 1-2 and combined use of EGFR- and Src-kinase inhibitors as neoadjuvant therapy in patients with colorectal cancer and potentially resectable liver metastases during Years2-4, Project 2 of a lead compound to modulate E-cadherin, and Project 4, the Tennessee Colorectal Polyp Study. Knowledge and insights gained from these trials will be used to design follow-up trials to be conducted within this SPORE and, when appropriate, assist in the development of larger, confirmatory trials to be conducted as inter-SPORE or cooperative group collaborations.

临床试验核心将提供开发、实施和协调方面的专业知识 在 GL SPORE 中进行的临床转化研究试验。最终目标是开发改进 通过更好地了解胃肠道癌症患者或有罹患胃肠道癌症风险的患者的治疗方法 这些癌症的生物学。为了实现这一目标，临床试验核心的主要职责将是 1) 提供与以下相关的转化临床试验的开发和实施方面的专业知识 孢子项目； 2) 确保并维持足够的患者参与 SPORE 发起的试验； 3）提供研究护士、数据管理员；以及这些临床试验的样本采购支持； 4） 监控并确保研究对象的安全，遵守机构和联邦法规 要求以及遵守协议规定的活动； 5）监督及时、准确的录入 将数据存入 OnCore 数据库。在上一个资助期内，临床试验核心提供了 支持四项治疗性临床试验，在范德比尔特招募了 65 名研究患者和 142 名患者 总体而言，一项流行病学研究，田纳西州结直肠息肉研究，招募了 3744 名患者。 该核心的努力对于协调与东部合作社联合进行的研究至关重要 肿瘤学组，从全组范围内登记的 25% 患者中获得配对肿瘤活检，并且 在范德堡大学注册的 19 名患者中，有 18 名患者 (95%) 发现了这种情况。在竞争性更新中，临床试验核心将 项目 1 中包含的支持试验包括对晚期晚期患者联合阻断 EGFR 轴 第 1-2 年结直肠癌以及联合使用 EGFR 和 Src 激酶抑制剂作为新辅助治疗 在第 2-4 年期间对结直肠癌和可能可切除的肝转移患者进行治疗， 项目 2 是调节 E-钙粘蛋白的先导化合物，项目 4 是田纳西州结直肠息肉研究。 从这些试验中获得的知识和见解将用于设计后续试验 该孢子，并在适当时协助开展更大规模的验证性试验 作为 SPORE 间或合作团体的协作。