Participant Recruitment, Enrollment and Characterization Core

参与者招募、登记和表征核心

• 批准号: 7727538
• 负责人: CHARLES DRESCHER
• 金额: $ 27.87万
• 依托单位: FRED HUTCHINSON CANCER RESEARCH CENTER
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-07-01 至 2014-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7727538
• 关键词: Academic Medical Centers; Advocacy; Arts; Biological; Biostatistics Core; Blood; California; Cancer Research Project; Cities; Clinical; Clinical Data; Clinical Trials; Collaborations; Collection; Communication; Community Physician; Consent; Databases; Development; Diagnosis; Enrollment; Follow-Up Studies; Funding; Future; Goals; Health Personnel; High Risk Woman; Image; Informatics; Instruction; Malignant neoplasm of ovary; Neoadjuvant Therapy; Ovarian; Participant; Patient Recruitments; Patients; Phase; Phase I Clinical Trials; Physicians; Pilot Projects; Procedures; Protocols documentation; Recruitment Activity; Recurrence; Reporting; Reproduction spores; Research; Research Activity; Research Personnel; Resource Sharing; Risk; Screening procedure; Serum Markers; Site; Specimen; Testing; Time; Woman; Work; anticancer research; cohort; efficacy trial; experience; follow-up; interest; meetings; novel; prevent; programs; research study; success; tumor

Clinical interaction with patients and health care providers is crucial to the success ofthe research studies proposed within the SPORE and to the long-term success of translational ovarian cancer research. The Patient Recruitment, Enrollment and Characterization Core (referred to in this document as the Clinical Core) provides the clinical expertise and the physician and patient interaction which is necessary for the successful completion of the research objectives of the SPORE projects and pilot activities. The POCRC Clinical Core has demonstrated a strong track-record in recruiting 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 3400 women have been enrolled into POCRC SPORE (n=1740) inter-SPORE (n=1112) and investigator initiated ROI funded (n= 637) ovarian cancer research projects. As in prior years, continued success ofthe Pacific Ovarian Cancer Research Consortium depends on the recruitment of participants into research studies including clinical trials. Building on our prior success and experience, the POCRC Clinical Core will refine participant contact and enrollment procedures to support all ofthe projects in this SPORE application as well as developmental research activities and collaborations within and outside ofthe SPORE. Working in concert-with the Clinical Specimen Management and Characterization Core and the Biostatistics and Informatics Core, the clinical core will identify participants for clinical trials and provide bio-specimens and associated clinical data that are necessary to meet the research objectives ofthe SPORE. The activities of the Clinical Core are expanding to include sites at Stanford University Medical Center, Palo Alto, California and City of Hope, Duarte, California. The addition of these sites is consistent with our goal of uniting major ovarian cancer research centers along the West Coast. RELEVANCE (See instructions): The goal of this ovarian SPORE is to demonstrate better strategies for 1) screening high-risk women using novel serum markers and state-of-the-art imaging without the need for another large trial, by integrating our Phase 1 trial results with reports from ongoing Phase 111 efficacy trials; 2) selecting women for neoadjuvant therapy by testing their blood for a resectability signature; and 3) immunizing women against their own tumors to prevent recurrence. Success in one or more of these efforts will significantly reduce the burden of ovarian cancer.

与患者和医疗保健提供者的临床互动对研究的成功至关重要 在SPORE内提出的，并转化卵巢癌研究的长期成功。的 患者招募、入组和表征核心（在本文件中称为临床核心） 提供了临床专业知识和医生和病人的互动，这是必要的成功 完成SPORE项目和试点活动的研究目标。 POCRC临床核心在招募大量女性队列方面表现出良好的记录， 患卵巢癌的风险（诊断前队列）和卵巢癌妇女在 诊断（事件病例队列）以及治疗和随访期间（诊断后队列）。采用均匀 协议的方法，同意，登记和跟踪参与者，超过3400名妇女已登记参加 POCRC SPORE（n=1740）、inter-SPORE（n=1112）和研究者启动的ROI资助（n= 637）卵巢 癌症研究项目。 与前几年一样，太平洋卵巢癌研究联盟的持续成功取决于 招募参与者参与研究，包括临床试验。在我们先前成功的基础上， 根据经验，POCRC临床核心将完善参与者联系和入组程序，以支持所有 本SPORE应用程序中的项目以及开发研究活动和合作 在孢子的内部和外部。与临床标本管理和 表征核心和生物统计学和信息学核心，临床核心将确定参与者， 临床试验，并提供生物标本和相关的临床数据，这是必要的，以满足研究 孢子的目标。临床中心的活动正在扩大，包括斯坦福大学的研究中心 大学医学中心，帕洛阿尔托，加州和希望之城，杜阿尔特，加州。添加这些 我们的目标是联合沿着西海岸的主要卵巢癌研究中心。 相关性（参见说明）： 这个卵巢孢子的目标是证明更好的策略：1）筛查高危妇女， 新的血清标志物和最先进的成像，而不需要另一个大的试验，通过整合我们的 I期试验结果和正在进行的111期疗效试验的报告; 2）选择女性进行新辅助治疗 通过测试她们的血液来获得可切除性特征的治疗;以及3）使妇女对自己的 防止肿瘤复发。如果这些努力中的一项或多项取得成功， 卵巢癌