Eval of Efficacy and Mechs of Anti-inflammatory Intervention for Mucosal Injury

2006年7月，位于南卡罗来纳州格林维尔卡罗莱纳州癌症中心的国家癌症研究所赞助的社区临床肿瘤学项目完成了礼宾现场启蒙访问。评分员可靠性培训已于2006年11月2日完成。CCOP在2007年招募了他们的第一个受试者，到目前为止，这个临床站点已经招募了两名患者。所有受试者均给予书面知情同意。收集所有数据，研究药物由受试者按照方案自行给药。依那西普漱口水/安慰剂由美国国立卫生研究院临床中心药物开发服务处生产。NINR研究协调中心适当地接收了所有数据和生物样本。马里兰大学机构审查委员会于2009年1月批准了这项协议，通过马里兰大学格林鲍姆癌症中心的血液和骨髓移植计划来实施。在完成NIH规定的协作监管流程后，首席调查员和研究护士将进行现场启动访问和评价员之间的可靠性培训，受试者招募将在该临床现场开始。

The protocol site initation visit was completed in July 2006 at the National Cancer Institute sponsored Community Clinical Oncology Program located at the Cancer Centers of the Carolinas, Greenville, SC. Interrater reliability training was completed November 2, 2006. The CCOP recruited their first subject in 2007, and two patients have been recruited to date at this clinical site. All subjects gave written informed consent. All data were collected, and study drug was self administered by subject per protocol. Etanercept mouthwash/placebo is prepared by the Pharmaceutical Development Service, Clinical Center, NIH. All data and biological samples were received appropriately by the NINR Study Coordinating Center. The University of Maryland institutional review board approved this protocol in January 2009 for implementation through the Blood and Marrow Transplantation Program, University of Maryland Greenebaum Cancer Center. Following completion of the NIH mandated regulatory processes for this collaboration, the site initation visit and interrater relibility training will be conducted by the principal investigator and the research nurse, and subject recruitment will begin at this clinical site.