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

粘膜损伤抗炎干预的疗效及机制评价

基本信息

批准号：
7969490
负责人：
jane fall-dickson
金额：
$ 16.67万
依托单位：
NATIONAL INSTITUTE OF NURSING RESEARCH
依托单位国家：
美国
项目类别：
财政年份：
资助国家：
美国
起止时间：
至
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/7969490
关键词：
16 year old Acute Allogenic Anti-Inflammatory Agents Anti-inflammatory Atrophic Autologous Binding Biological Blood Bone Marrow Transplantation Cancer Center Chimeric Proteins Clinical Clinical Services Clinical Trials Data Monitoring Committees Collaborations Community Clinical Oncology Program Complex Data Development Edema Erythema Etanercept Healed Hematopoietic Stem Cell Transplantation Incidence Inflammation Inflammatory Inflammatory Response Informed Consent Injury Intervention Maryland Measures Mediator of activation protein Monitor Mouthwash Mucous Membrane National Cancer Institute Nursing Research Oral Oral cavity Oral mucous membrane structure Oropharyngeal Pain Pathogenesis Patient Care Patients Peripheral Blood Stem Cell Pharmaceutical Preparations Pharmacologic Substance Placebos Plasma Prevention Principal Investigator Process Protocols documentation Quality of life Randomized Randomized Controlled Clinical Trials Recruitment Activity Research Ethics Committees Role Safety Saliva Sampling Schedule Science Self-Administered Severities Signal Transduction Site Specific qualifier value Stomatitis Testing Time Tissues Toxic effect Training Treatment-Related Cancer Tumor Necrosis Factor-alpha Tumor Necrosis Factors Ulcer United States National Institutes of Health Universities Visit Writing chemotherapy clinical research site cytokine experience healing improved insight novel oncology oral condition prevent programs receptor tool treatment strategy

项目摘要

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.

方案现场初始访问于 2006 年 7 月在国家癌症研究所资助的位于南卡罗来纳州格林维尔卡罗莱纳州癌症中心的社区临床肿瘤学项目中完成。评估者间可靠性培训于 2006 年 11 月 2 日完成。CCOP 于 2007 年招募了第一个受试者，迄今为止，该临床中心已招募了两名患者。所有受试者均签署了书面知情同意书。收集所有数据，并根据方案由受试者自行施用研究药物。依那西普漱口水/安慰剂由 NIH 临床中心药物开发服务处制备。所有数据和生物样本均由 NINR 研究协调中心适当接收。马里兰大学机构审查委员会于 2009 年 1 月批准了该方案，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实施。在完成 NIH 规定的本次合作监管流程后，主要研究者和研究护士将进行现场启动访问和参与者间可靠性培训，并且受试者招募将在该临床现场开始。