Impact of Family History of Colon Cancer on Adenomas in 40-49 Year Olds

结肠癌家族史对 40-49 岁腺瘤的影响

• 批准号: 7931847
• 负责人: PHILIP S SCHOENFELD
• 金额: --
• 依托单位: VETERANS HEALTH ADMINISTRATION
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-07-01 至 2013-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7931847
• 关键词: Abdomen; Address; Age; Cancerous; Cohort Studies; Colon Carcinoma; Colonic Polyps; Colonoscopy; Colorectal Cancer; Conflict (Psychology); Constipation; Data; Diagnosis; Diarrhea; Dysplasia; Enrollment; Family; Family history of; First Degree Relative; Funding; Goals; Guidelines; Habits; Health system; Healthcare; Hematochezia; Individual; Informed Consent; Intestines; Lead; Literature; Location; Logistic Regressions; Malignant Neoplasms; Medical center; Michigan; Morphology; National Cancer Institute; Pathology Report; Patient Recruitments; Patient Self-Report; Patients; Performance; Polyps; Population; Prevalence; Publishing; Recommendation; Recording of previous events; Regression Analysis; Relative Risks; Reporting; Resources; Risk; Risk Factors; Sample Size; Site; Societies; Specificity; Surveys; Symptoms; Veterans; Villous Adenoma; adenoma; base; colorectal cancer screening; inclusion criteria; prevent; prospective; standard of care; tv watching

DESCRIPTION (provided by applicant): IMPACT OF FAMILY HISTORY OF CRC ON ADENOMAS IN 40-49 YEAR OLDS BACKGROUND: The goal of CRC screening is to prevent cancer by identifying and removing advanced pre- cancerous polyps (i.e., advanced adenomas defined as adenomas > 10 mm, villous adenomas, adenomas with high-grade dysplasia) during colonoscopy. Current guidelines from academic societies and VA Directives provide different recommendations about the need to perform colonoscopy in 40-49 year olds with a family history of CRC in a first-degree relative (FDR). We hypothesize that 40-49 year old individuals with a family history of CRC will have an increased risk of advanced adenoma compared to age-matched controls. OBJECTIVES: (A) To estimate the absolute prevalence of advanced adenomas among 40-49 year old individuals with a family history of CRC and to compare this absolute prevalence versus the absolute prevalence of advanced adenomas in 40-49 year old "average-risk" individuals with scant hematochezia, abdominal discomfort, or altered bowel habits (i.e., constipation or diarrhea) as their indication for colonoscopy; (B) Identify risk factors associated with advanced adenomas or adenomas (any size) among 40-49 year old individuals with a family history of CRC using multiple logistic regression analysis. METHODS: This is a multi-center, prospective cohort study conducted at four sites (Ann Arbor VAHS, Durham VAHS, U. of Michigan Health System, and the National Naval Medical Center, Bethesda, MD). Inclusion criteria: 40-49 year old asymptomatic individuals referred for colonoscopy due to a family history of CRC AND 40-49 year old individuals without a family history of CRC or colon polyps who are referred for colonoscopy to evaluate scant hematochezia, abdominal discomfort or altered bowel habits. [Note: Although performance of colonoscopy is the "standard of care" to evaluate these symptoms, the presence of these symptoms is NOT associated with an increased risk of advanced adenomas in 40-49 year olds. Therefore, colonoscopy can be justified in these patients AND these patients represent an "average-risk" population for advanced adenomas.] After obtaining informed consent from study patients, we will gather data on the size, morphology, and location of polyps from colonoscopy report forms and polyp pathology reports. Study patients will also complete a risk factor survey for adenomas which has been adapted from a National Cancer Institute survey. Patient self-report of family history of CRC will be used since published literature demonstrates 86-93% sensitivity and 92-100% specificity for self-report of this family history. Sample size for this study has been set at 1940 patients which will be sufficient to quantify a relative risk of 2.0 for advanced adenomas in 40-49 year old individuals with a family history of CRC if the absolute prevalence of advanced adenomas is at least 4.0%. Pilot funding has been obtained, and patient recruitment has already been initiated at two sites. On August 31, 2009, 160 patients had been enrolled and recruitment has increased to 7-8 patients per week. PUBLIC HEALTH RELEVANCE: 7.9 million Veterans receive health care in the VA. Approximately 10% or 790,000 have a first-degree relative (FDR) with colorectal cancer (CRC). Should any of these patients undergo colonoscopy at age 40 due to an increased prevalence of advanced adenomas? There is not adequate prospective data in 40-49 year olds with this family history to answer this question. Guidelines provide conflicting recommendations about performing colonoscopy at age 40 or 50 in these patients, but guidelines emphasize that prospective data are needed to clarify recommendations. The 2007 VA CRC Directive states that individuals with a FDR with CRC <60 years old are to get colonoscopy at age 40, but individuals with a FDR with CRC > 60 may get colonoscopy at age 40. VA endoscopic resources are limited. This study will determine if hundreds of thousands of Veterans should get colonoscopy starting at age 40 or age 50.

描述（由申请人提供）： CRC 家族史对 40-49 岁人群腺瘤的影响 背景：CRC 筛查的目标是通过在结肠镜检查期间识别和切除晚期癌前息肉（即晚期腺瘤定义为 > 10 mm 的腺瘤、绒毛状腺瘤、高度不典型增生的腺瘤）来预防癌症。目前学术协会的指南和 VA 指令针对一级亲属 (FDR) 有 CRC 家族史的 40-49 岁人群是否需要进行结肠镜检查提供了不同的建议。我们假设，与年龄匹配的对照相比，有 CRC 家族史的 40-49 岁个体患晚期腺瘤的风险会增加。目的：(A) 估计有 CRC 家族史的 40-49 岁个体中晚期腺瘤的绝对患病率，并将该绝对患病率与以少量便血、腹部不适或排便习惯改变（即便秘或腹泻）为指征的 40-49 岁“平均风险”个体中晚期腺瘤的绝对患病率进行比较 结肠镜检查； (B) 使用多元逻辑回归分析，在有 CRC 家族史的 40-49 岁个体中识别与晚期腺瘤或腺瘤（任何大小）相关的风险因素。方法：这是一项在四个地点（安娜堡 VAHS、达勒姆 VAHS、密歇根大学卫生系统和马里兰州贝塞斯达国家海军医疗中心）进行的多中心前瞻性队列研究。纳入标准：因 CRC 家族史而转诊进行结肠镜检查的 40-49 岁无症状个体，以及无 CRC 或结肠息肉家族史且转诊进行结肠镜检查以评估便血、腹部不适或排便习惯改变的 40-49 岁个体。 [注：虽然结肠镜检查是评估这些症状的“护理标准”，但这些症状的存在与 40-49 岁人群患晚期腺瘤的风险增加无关。因此，对这些患者进行结肠镜检查是合理的，并且这些患者代表了晚期腺瘤的“平均风险”人群。]在获得研究患者的知情同意后，我们将从结肠镜检查报告表和息肉病理报告中收集有关息肉大小、形态和位置的数据。研究患者还将完成一项腺瘤风险因素调查，该调查改编自美国国家癌症研究所的调查。将使用患者自我报告的 CRC 家族史，因为已发表的文献表明该家族史的自我报告的敏感性为 86-93%，特异性为 92-100%。本研究的样本量设定为 1940 名患者，如果晚期腺瘤的绝对患病率至少为 4.0%，则足以量化有 CRC 家族史的 40-49 岁个体晚期腺瘤的相对风险为 2.0。试点资金已经获得，两个地点已经开始招募患者。 2009年8月31日，已招募了160名患者，招募人数已增加至每周7-8名患者。 公共卫生相关性： 790 万退伍军人在退伍军人管理局接受医疗保健。大约 10% 或 790,000 人的一级亲属 (FDR) 患有结直肠癌 (CRC)。由于晚期腺瘤患病率增加，这些患者是否应该在 40 岁时接受结肠镜检查？对于有此家族史的 40-49 岁人群，没有足够的前瞻性数据来回答这个问题。对于这些患者在 40 岁或 50 岁进行结肠镜检查，指南提供了相互矛盾的建议，但指南强调需要前瞻性数据来澄清建议。 2007 年 VA CRC 指令规定，患有 CRC <60 岁的 FDR 的个体应在 40 岁时接受结肠镜检查，但患有 CRC > 60 的 FDR 的个体可能会在 40 岁时接受结肠镜检查。VA 内窥镜资源有限。这项研究将确定数十万退伍军人是否应该从 40 岁或 50 岁开始接受结肠镜检查。