Core--Clinical

核心--临床

• 批准号: 6989600
• 负责人: CHARLES DRESCHER
• 金额: $ 15.81万
• 依托单位: FRED HUTCHINSON CANCER RESEARCH CENTER
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-30 至 2009-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6989600
• 关键词: biomedical facility; clinical research; clinical trials; human subject; medical outreach /case finding; neoplasm /cancer diagnosis; ovary neoplasms; patient care management; patient care personnel relations; women' s health

DESCRIPTION (provided by applicant): Clinical interaction with patients and health care providers is crucial to the success of each research study proposed within the SPORE, and to the long-term success of a translational program of ovarian cancer research. The primary aim of the Clinical Core is to provide the clinical expertise, including physician and patient interaction that is necessary for the successful completion of the research objectives of the SPORE studies and potential pilot activities. The POCRC Clinical Core has a proven track record in recruiting, from a broad array of facilities, large cohorts of women at risk for developing ovarian cancer (pre-diagnosis cohort) and women with ovarian cancer at the time of diagnosis (incident cases cohort) and during treatment and follow-up (post diagnosis cohort). Using uniform protocols to approach, consent, enroll and track participants over 1200 women have been enrolled into POCRC SPORE (n=506) inter-SPORE collaborations (n=177) and investigator initiated RO1 funded (n= 592) ovarian cancer research projects. Clinical, pathological and epidemiological data are collected from all participants using standardized data collection instruments. The Clinical Core also includes a Physicians Advisory Committee (PAC) and a Patient Advocacy Group (PAG). The PAC works to ensure that as many participants as possible are included in the research and that the goals and progress of the research are disseminated into the clinical community. The Patient Advocacy Group works directly with researchers at all levels of the SPORE program ensuring that ovarian cancer patients are represented in all phases of the research, particularly those that involve interactions with patients and women at risk for ovarian cancer. Although successful, it is essential that the Clinical Core evolve to meet the changing focus of our SPORE program. Specifically we are proposing to incorporate the following within the existing Core 1) a Clinical Trials Research Support Network to facilitate the conduct of our Phase I trials of immunotherapy and ovarian cancer screening and the translation of therapeutic strategies resulting from laboratory based investigations into Phase I human clinical trials; and 2) a minority outreach network to increase enrollment of minority women into the research program.

描述（由申请人提供）：与患者和医疗保健提供者的临床互动对于SPORE内提出的每项研究的成功以及卵巢癌研究转化计划的长期成功至关重要。临床核心的主要目的是提供临床专业知识，包括成功完成SPORE研究和潜在试点活动的研究目标所必需的医生和患者互动。POCRC临床核心在从广泛的设施中招募大量有卵巢癌风险的女性（诊断前队列）和诊断时患有卵巢癌的女性（事件病例队列）以及治疗和随访期间（诊断后队列）方面有着良好的记录。使用统一的协议来接近、同意、招募和跟踪参与者，超过1200名妇女已被招募到POCRC SPORE（n=506）间SPORE合作（n=177）和研究者发起的RO 1资助（n= 592）卵巢癌研究项目中。使用标准化数据收集工具从所有参与者收集临床、病理和流行病学数据。临床核心还包括一个医生咨询委员会（PAC）和一个患者倡导小组 （PAG）。PAC致力于确保尽可能多的参与者被纳入研究，并将研究的目标和进展传播到临床社区。患者倡导小组直接与SPORE计划的各级研究人员合作，确保卵巢癌患者在研究的所有阶段都有代表，特别是那些涉及与卵巢癌患者和女性风险互动的研究。虽然取得了成功，但临床核心必须不断发展，以满足我们SPORE计划不断变化的重点。具体而言，我们建议在现有核心中纳入以下内容：1）临床试验研究支持网络，以促进我们进行免疫治疗和卵巢癌筛查的I期试验，并将基于实验室的研究产生的治疗策略转化为I期人体临床试验; 2）少数民族外展网络，以增加少数民族妇女参与研究计划。