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

方案研究中心启动访视于2006年7月在美国国家癌症研究所申办的社区临床肿瘤学项目完成，该项目位于南卡罗来纳州格林维尔的美国国家癌症研究所癌症中心。评估者间可靠性培训于2006年11月2日完成。CCOP于2007年招募了第一例受试者，迄今为止，该临床研究中心已招募了2例患者。 所有受试者均提供了书面知情同意书。收集所有数据，受试者按照方案自行给予研究药物。依那西普漱口水/安慰剂由NIH临床中心药物开发服务部制备。所有数据和生物样本均由NINR研究协调中心适当接收。马里兰州大学机构审查委员会于2009年1月批准了本方案，通过马里兰州Greenebaum癌症中心的血液和骨髓移植项目实施。在完成NIH规定的该合作监管流程后，主要研究者和研究护士将进行研究中心启动访视和评估者间可靠性培训，受试者招募将在该临床研究中心开始。

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.