PHASE IIA CLINICAL BIOMARKER TRIAL OF ASPIRIN AND ARGININE RESTRICTION IN COLON

结肠中阿司匹林和精氨酸限制的 IIA 期临床生物标志物试验

• 批准号: 8166933
• 负责人: Jason Zell
• 金额: $ 0.12万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-12-01 至 2010-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8166933
• 关键词: Affect; Arginine; Aspirin; Biological Markers; Biopsy; Blood; California; Cancer Patient; Chemicals; Clinical; Clinical Trials; Collection; Colon; Colon Carcinoma; Colorectal Cancer; Computer Retrieval of Information on Scientific Projects Database; Development; Diagnosis; Endoscopy; Enrollment; Event; Funding; Future; Genus Cola; Grant; Institution; Intake; Intervention; Intervention Studies; Intestines; Knowledge; Laboratory Study; Measures; Medical center; Oral; Patients; Persons; Phase; Polyamines; Procedures; Prostaglandins; Rectum; Recurrence; Research; Research Personnel; Resources; Risk; Source; Tissue Sample; Tissues; United States National Institutes of Health; Universities; Urine; Venous blood sampling; design; dietary restriction; high risk; research study

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The purpose of this research study is to understand the effects of oral aspirin taken daily with an arginine-restricted diet on certain colorectal cancer biomarkers in treated colon cancer patients. Patients with colon cancer are at high risk for recurrence and for development of secondary colorectal cancers in the future. Specific chemicals (polyamines, prostaglandins) in the body referred to as biomarkers can be measured to help understand a person s risk for developing colorectal cancer. Specific biomarkers associated with colorectal cancer have been identified in prior laboratory studies. By measuring these predefined biomarkers before and after the study intervention, we can assess how they are affected by the intervention, and gain knowledge about their usefulness in colon cancer patients on clinical trial. This study is a Phase IIa clinical biomarker study, using oral aspirin 325 mg taken daily with an arginine-restricted diet designed to reduce arginine intake by at least 30% during the 12-week study period. The biomarkers will be obtained from patient by performing endoscopy (a procedure used to look at the inside of the bowel, rectum and colon) and biopsy (taking samples of tissue), phlebotomy (drawing blood), and urine collection. Biopsies are done to evaluate changes in tissue content that may relate to early events in colon cancer formation. This was the procedure used to diagnose your condition initially. There will be 24 patients enrolled into this study performed through University of California Irvine Medical Center.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 本研究的目的是了解每天口服阿司匹林并限制精氨酸饮食对接受治疗的结肠癌患者的某些结直肠癌生物标志物的影响。 结肠癌患者未来复发和继发性结直肠癌的风险很高。 体内被称为生物标志物的特定化学物质（多胺、前列腺素）可以通过测量来帮助了解一个人患结直肠癌的风险。 先前的实验室研究已鉴定出与结直肠癌相关的特定生物标志物。 通过在研究干预之前和之后测量这些预定义的生物标志物，我们可以评估它们如何受到干预的影响，并了解它们在临床试验中对结肠癌患者的有用性。 这项研究是一项 IIa 期临床生物标志物研究，每天口服 325 毫克阿司匹林，并采用限制精氨酸的饮食，旨在在 12 周的研究期间将精氨酸摄入量减少至少 30%。通过进行内窥镜检查（一种用于观察肠、直肠和结肠内部的程序）和活检（采集组织样本）、静脉切开术（抽血）和尿液收集，从患者身上获取生物标志物。 进行活检是为了评估可能与结肠癌形成的早期事件相关的组织内容的变化。这是最初用于诊断您的病情的程序。 将有 24 名患者参加这项由加州大学欧文分校医学中心进行的研究。