Colorectal Neoplasia in SELECT Participants

选定参与者的结直肠肿瘤

• 批准号: 7663149
• 负责人: M. Peter Lance
• 金额: $ 51.74万
• 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/7663149
• 关键词: Address; Adenomatous Polyps; Ancillary Study; Architecture; Aspirin; Benign; Body mass index; Caliber; Cancer Etiology; Cessation of life; Chemopreventive Agent; Clinical; Clinical Trials; Colon Carcinoma; Colonoscopy; Colorectal; Colorectal Adenoma; Colorectal Cancer; Colorectal Neoplasms; Colorectal Polyp; Cost Savings; Data Collection; Dysplasia; Endoscopy; Epithelial; Excision; Funding; Histologic; Histopathology; Incidence; Intervention; Intervention Trial; L-Selenomethionine; Location; Malignant Neoplasms; Malignant neoplasm of prostate; Measures; Modification; Neoplasms; Parents; Participant; Patients; Pharmaceutical Preparations; Phase; Polypectomy; Population; Population Study; Prevalence; Prevention program; Procedures; Process; Protocols documentation; Randomized; Recurrence; Reporting; Research Infrastructure; Research Personnel; Resources; Role; Selenium; Sigmoidoscopy; Tissues; United States; Villous; Vitamin E; adenoma; cancer chemoprevention; cancer diagnosis; cancer prevention; cancer recurrence; clinical care; dietary supplements; male; men; neoplastic; prevent; programs; 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。腺瘤性息肉或结直肠腺瘤 (CRA) 是 CRC 的良性肿瘤前体，尽管大多数 CRA 不会进展为 CRC，并且并非所有结直肠息肉都是腺瘤。既往患有 CRA 的患者中，复发性 CRA 的发病率每年为 10-15%，可作为 CRC 化学预防试验的终点。大量间接证据支持硒对结直肠癌具有化学预防作用。 SELECT 试验将评估硒（L-硒代蛋氨酸）和维生素 E 单独使用以及联合使用对 35,584 名随机男性受试者中前列腺癌临床发病率的影响。 SELECT 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 生存率的影响。当前申请的长期目标是解决母体 SELECT 试验中与 CRC 相关的次要目标。具体目标是衡量 SELECT 干预措施对 SELECT 参与者中 CRA 患病率的影响，并同时比较治疗与这些干预措施对该研究人群中 CRC 发病率和 CRA 患病率的影响。 CRA 患病率将根据 SELECT 参与者的手术和组织病理学报告来确定，这些参与者在试验期间接受下消化道内窥镜检查（乙状结肠镜检查或结肠镜检查）并切除结直肠息肉，作为其常规临床护理的一部分。 CRC 发病率将根据已制定的 SELECT 试验方案确定，以确定试验期间参与者诊断出的所有非前列腺癌。该申请的首席研究员（PI）也是结肠癌预防计划项目（CCPPP）的PI，该项目包括一项多中心III期随机硒CRA复发试验。现有的 SELECT Trial 和 CCPPP 基础设施将用于所有数据收集和分析，从而节省大量成本。拟议的 SELECT 参与者结直肠肿瘤（CRA 和 CRC）研究的一个独特之处是有机会在同一（SELECT）研究人群中调查试验干预措施对结直肠腺瘤和癌症终点的影响。这项研究解决了一个尚未解答的主要问题：预防结直肠腺瘤复发的药物是否也可以预防结直肠癌？这个问题是在一项已经建立的临床试验的背景下得到解决的。