Core--Clinical

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孢子内提出的每项研究研究的成功以及卵巢癌研究翻译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，包括成功完成孢子研究的研究目标和潜在的试点活动所必需的医生和患者互动。POCRC临床核心在从广泛的机构中招募大量有患卵巢癌风险的妇女(诊断前队列)和在诊断时(发病病例队列)以及在治疗和后续治疗期间(诊断后队列)患有卵巢癌的妇女方面有着良好的记录。使用统一的协议接近、同意、登记和跟踪参与者已有1200多名妇女参加了POCRC孢子(n=506)孢子间合作(n=177)，研究人员发起了RO1资助的卵巢癌研究项目(n=592)。使用标准化的数据收集工具从所有参与者那里收集临床、病理和流行病学数据。临床核心还包括医生咨询委员会(PAC)和患者倡导小组 (PAG)。委员会的工作是确保尽可能多的参与者参与研究，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孢子计划各级研究人员合作，确保卵巢癌患者参与研究的所有阶段，特别是那些涉及与卵巢癌患者和有卵巢癌风险的女性互动的阶段。尽管取得了成功，但临床核心的发展必须满足我们孢子计划不断变化的重点。具体地说，我们正在提议将以下内容纳入现有的核心项目：1)临床试验研究支持网络，以促进我们的免疫疗法和卵巢癌筛查第一阶段试验的进行，并将基于实验室调查的治疗策略转化为第一阶段人类临床试验；以及2)少数族裔外联网络，以增加少数族裔妇女加入研究计划。

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.