Colorectal Neoplasia in SELECT Participants

选定参与者的结直肠肿瘤

• 批准号: 7492116
• 负责人: M. Peter Lance
• 金额: $ 53.52万
• 依托单位: UNIVERSITY OF ARIZONA
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-04 至 2012-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7492116
• 关键词: Address; Adenomatous Polyps; Ancillary Study; Architecture; Aspirin; Benign; Body mass index; Caliber; Cancer Etiology; Caring; Cessation of life; Chemoprevention; Chemopreventive Agent; Clinical; Clinical Trials; Colon Carcinoma; Colonoscopy; Colorectal; Colorectal Adenoma; Colorectal Cancer; Colorectal Neoplasms; Colorectal Polyp; Cost Savings; Data Collection; Dysplasia; End Point; Endoscopy; Epithelial; Excision; Funding; Histologic; Histopathology; Incidence; Intervention; Intervention Trial; L-Selenomethionine; Location; Malignant Neoplasms; Malignant neoplasm of prostate; Measures; Medical Surveillance; Modification; Neoplasms; Numbers; Parents; Participant; Patients; Pharmaceutical Preparations; Phase; Polypectomy; Population; Population Study; Prevalence; Prevention program; Procedures; Process; Protocols documentation; Randomized; Rate; Recurrence; Reporting; Research Infrastructure; Research Personnel; Resources; Role; Selenium; Selenium/vitamin E; Sigmoidoscopy; Tissues; United States; Villous; Vitamin E; adenoma; cancer diagnosis; cancer prevention; cancer recurrence; dietary supplements; male; men; neoplastic; prevent; programs; size; treatment effect

DESCRIPTION (provided by applicant): Colorectal cancer (CRC) is the second leading cause of cancer deaths in the United States. Adenomatous polyps or colorectal adenomas (CRAs) are the benign neoplastic precursors of CRCs, although most CRAs do not progress to CRC and not all colorectal polyps are adenomas. Recurrent CRAs develop at a rate of 10-15% per year in patients with previous CRAs and serve as endpoints in CRC chemoprevention trials. Considerable indirect evidence supports a chemopreventive role for selenium against CRC. The SELECT Trial will assess the effect of selenium, as L-selenomethionine, and vitamin E alone and in combination on the clinical incidence of prostate cancer in 35,584 now-randomized male subjects. Planned secondary objectives of SELECT include assessment of the effect of selenium and vitamin E on CRC incidence and CRC-free survival. The long-term objective of the current application is to address the CRC-related secondary objectives of the parent SELECT Trial. Specific Aims are to measure the effects of SELECT interventions on CRA prevalence in SELECT participants and to compare concurrently the effects of treatment with these interventions on CRC incidence and CRA prevalence in this study population. CRA prevalence will be determined from the procedure and histopathology reports of SELECT participants who undergo lower gasatrointestinal endoscopy (sigmoidoscopy or colonoscopy) and removal of colorectal polyps as part of their usual clinical care while in the trial. CRC incidence will be determined from a SELECT Trial protocol already in place to ascertain all non-prostate cancers diagnosed in participants while in the trial. The Principle Investigator (PI) of this application is also PI of the Colon Cancer Prevention Program Project (CCPPP), which includes a multi-center Phase III randomized selenium CRA recurrence trial. Existing SELECT Trial and CCPPP infrastructure will be utilized for all data collection and analyses, with consequent substantial cost savings. A unique aspect of the proposed study of colorectal neoplasia (CRAs and CRCs) in SELECT participants is the opportunity to investigate the effects of trial interventions on colorectal adenoma and cancer endpoints in the same (SELECT) study population. This study addresses a major unanswered question: Do agents that prevent recurrence of colorectal adenomas also prevent colorectal cancer? The question is addressed in the context of an already established clinical trial.

描述（由申请人提供）：结直肠癌（CRC）是美国癌症死亡的第二大原因。腺瘤息肉或结直肠腺瘤（CRA）是CRC的良性肿瘤前体，尽管大多数CRA都没有发展为CRC，而并非所有结直肠息肉都是腺瘤。以前的CRA患者每年以每年10-15％的速度发育，并且在CRC化学预防试验中充当终点。大量间接证据支持硒对CRC的化学预防作用。选定试验将评估硒的作用，即单独使用的l-苯甲米汀和维生素E，并组合对35,584名现有男性受试者的前列腺癌的临床发生率。精选的计划的次要目标包括评估硒和维生素E对CRC发病率和无CRC生存的影响。当前应用程序的长期目标是解决父级选择试验的与CRC相关的二级目标。具体的目的是衡量某些干预措施对选定参与者中CRA患病率的影响，并将治疗与这些干预措施对CRC发病率和CRA患病率的影响同时进行比较。 CRA患病率将从经过较低气体内窥镜检查（乙状结肠镜检查或结肠镜检查）的选定参与者的程序和组织病理学报告确定，并在试验中去除结直肠息肉的一部分。 CRC发病率将从已经到位的选定试验方案中确定，以确定在试验中诊断出参与者的所有非局部癌症。该应用的主要研究者（PI）也是结肠癌预防计划项目（CCPPP）的PI，其中包括多中心III期随机硒CRA复发试验。现有的选择试验和CCPPP基础架构将用于所有数据收集和分析，并节省大量成本。在某些参与者中提议的结直肠肿瘤（CRA和CRC）研究的独特方面是研究试验干预措施对同一（选择）研究人群中结直肠腺瘤和癌症终点的影响的机会。这项研究解决了一个主要的未解决问题：防止结直肠腺瘤复发的药物是否也可以预防大肠癌？这个问题是在已经建立的临床试验的背景下解决的。