: A Phase Ib Biomarker Trial of Naproxen in Patients at Risk for DNA Mismatch

：对有 DNA 错配风险的患者进行萘普生 Ib 期生物标志物试验

• 批准号: 8762954
• 负责人: TERISA DAVIS
• 金额: $ 105.08万
• 依托单位: UNIVERSITY OF TX MD ANDERSON CAN CTR
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-20 至 2017-09-19
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8762954
• 关键词: Address; Adenomatous Polyps; Area; Biological Markers; Biopsy; Cancer Center; Clinical; Colon Carcinoma; Colorectal; Colorectal Cancer; DNA; Dinoprostone; Dose; Future; Gene Expression; Genomics; Inflammation; Institution; Measures; Messenger RNA; Michigan; MicroRNAs; Mismatch Repair; Mucous Membrane; Naproxen; Non-Steroidal Anti-Inflammatory Agents; Pain; Patients; Phase; Placebos; Plasma; Polyps; Population; Residual state; Risk; Series; Tissues; Toxic effect; Universities; prostaglandin M; rectal; transcriptomics; urinary

The proposed trial shall address whether Naproxen, a nonsteroidal anti-inflammatory agent in widespread clinical use primarily for the treatment of pain and inflammation, can safely and effectively be given in a once daily dose to subjects at risk for a mismatch repair deficient colon carcinoma, and how and whether it modulates a series of biomarkers and other parameters in this specific population. The trial shall be performed at the MD Anderson Cancer Center, the Dana Farber Cancer Center and the University of Michigan. All three institutions shall participate in the various aspects of the trial.

拟开展的试验应解决Nauricen（一种广泛临床使用的非甾体抗炎药，主要用于治疗疼痛和炎症）是否可以安全有效地每日一次给予有错配修复缺陷结肠癌风险的受试者，以及它如何以及是否调节该特定人群中的一系列生物标志物和其他参数。本试验应在MD安德森癌症中心、Dana Farber癌症中心和密歇根大学进行。所有三个机构都应参与审判的各个方面。