Clinical Risk Factors for Barretts Esophagus in a Primary Care Setting

初级保健机构中巴雷特食管的临床危险因素

• 批准号: 7683278
• 负责人: BLAIR Anderson JOBE
• 金额: $ 15.23万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-15 至 2011-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7683278
• 关键词: Address; Adult; Area; Barrett Esophagus; Barrett' s Adenocarcinoma; Caliber; Chronic; Clinical; Clinical Trials; Clinical assessments; Colonoscopy; Coughing; Cross-Over Studies; Cross-Sectional Studies; Development; Diagnosis; Disease Progression; Early Diagnosis; Endoscopy; Enrollment; Epidemiology; Esophageal; Esophageal Adenocarcinoma; Gastroesophageal reflux disease; General Population; Hoarseness; Incidence; Individual; Malignant Neoplasms; Malignant neoplasm of esophagus; Mechanics; Methods; Modeling; National Institute of Diabetes and Digestive and Kidney Diseases; Nomograms; Otolaryngology; Participant; Pathogenesis; Pathology; Patients; Population; Premalignant; Preparation; Prevalence; Prevalence Study; Prevention; Primary Health Care; Probability; Procedures; Protocols documentation; Provider; Randomized; Reflux; Reporting; Research Infrastructure; Research Personnel; Risk; Risk Factors; Safety; Sample Size; Sampling; Screening for cancer; Screening procedure; Sedation procedure; Sensitivity and Specificity; Series; Severities; Site; Staging; Stratification; Survival Rate; Symptoms; Techniques; Technology; Time; Uncontrolled Study; United States; Validity and Reliability; Work; advanced disease; cancer diagnosis; cancer risk; carcinogenesis; cost; data management; high risk; improved; novel; outcome forecast; primary care setting; programs; protocol development; public health relevance; success

DESCRIPTION (provided by applicant): Most patients who develop esophageal adenocarcinoma (EAC) are unaware of the presence of Barrett's esophagus (BE) prior to cancer diagnosis, and 57% have never reported chronic symptoms of gastroesophageal reflux disease (GERD), the current trigger for screening. Thus, the majority of patients who are at risk for the development of EAC are never screened for BE and present with advanced incurable cancer. Our preliminary work has been directed at understanding the relationship between symptoms of GERD, laryngopharyngeal symptoms of reflux, and BE using novel, less invasive methods of screening. We compared in-office unsedated small-caliber endoscopy in a randomized, cross-over trial to conventional sedated endoscopy and established equivalent accuracy in detecting BE with excellent patient tolerability. For the first time, we now have an efficient method to be used for population screening with high acceptance. Dr. Jobe's group has systematically screened otolaryngology patients with cough and hoarseness for BE. Results indicate that the BE prevalence in these subjects, a population not routinely screened, is equivalent to that in a population with classic and chronic GERD symptoms. Finally, in preparation for a multi-center prevalence study, the Barrett's Esophagus Risk Consortium (BERC) was created. BERC consists of 10 centers which are stragically placed across the US, and all participants are internationally recognized experts in BE epidemiology. The next critical step in this work will be to understand the risk for BE an unselected population so that we can narrowly tailor screening efforts. The purpose of this R21 in application is to further develop protocol mechanics in anticipation of the first BERC U-series proposal directed toward the NIDDK Clinical Trials Program with the following specific aims:1) to determine the prevalence of BE within a representative sample of the Nation's primary care population as a surrogate for the US population; 2) develop a clinical risk factor probability model that predicts the presence of BE; 3) construct and validate a nomogram that incorporates the most potent risk factors as a guide for determining endoscopic screening threshold. This R21 proposal centers on further developing the most optimal methods for subject enrollment, data management, sample size determination, and developing a protocol for multi-center endoscopic screening in primary care patients which will be essential to the eventual success of a large scale trial. PUBLIC HEALTH RELEVANCE This work addresses critical deficits in our understanding of esophageal cancer risk by incorporating a novel screening technology into a consortium study which will for the first time, determine the prevalence and risk of Barrett's esophagus in an unselected U.S. population. This work will enable providers to identify high-risk individuals with Barrett's esophagus, the pre-malignant condition which leads to esophageal cancer, and enroll them into endoscopic surveillance. The end result will be highly focused risk stratification and prevention or improved survival through early detection.

描述（由申请人提供）：大多数发育食管腺癌（EAC）的患者在癌症诊断前没有意识到Barrett的食管（BE）的存在，而57％的患者从未报告过胃食管反流病疾病的慢性症状（GERD），目前触发了筛查。因此，大多数处于EAC发展风险的患者从未被筛查，并出现晚期无法治愈的癌症。我们的初步工作旨在了解GERD症状，喉咽症状反流的症状之间的关系，并使用新颖的，不太侵入性的筛查方法。我们在一项随机的，交叉试验中与常规镇静的内窥镜检查中的办公室内部未经培训的小型内窥镜检查进行了比较，并在检测出良好的患者耐受性方面确定了等效的准确性。现在，我们第一次有一种有效的方法用于人口筛查，并接受了高度接受。乔布博士的小组已系统地筛选了咳嗽和嘶哑的BE的耳鼻喉科患者。结果表明，在这些受试者中的普遍性（未经常筛查的人群）等同于具有经典和慢性GERD症状的人群中的人群。最后，为了准备多个中心的患病率研究，创建了巴雷特的食管风险财团（BERC）。 BERC由10个中心组成，这些中心遍布整个美国，所有参与者都是国际认可的BE流行病学专家。这项工作的下一个关键步骤是了解成为未选择人群的风险，以便我们可以狭义地量身定制筛查工作。该R21在应用中的目的是进一步开发方案机制，以期预期针对NIDDK临床试验计划的第一个BERC U系列提案，其目的具有以下具体目的：1）确定在国家代表性的初级保健人群中，作为美国人群的代表性的普遍存在； 2）开发一个预测BE存在的临床风险因素概率模型； 3）构建并验证列诺图，该图将最有效的风险因素纳入确定内窥镜筛查阈值的指南。该R21提案集中在进一步开发用于受试者入学，数据管理，样本量确定的最佳方法，并为初级保健患者的多中心内窥镜筛查制定协议，这对于大规模试验的最终成功至关重要。公共卫生相关性这项工作通过将新颖的筛查技术纳入财团研究中，解决了我们对食管癌风险的关键缺陷，该研究将首次确定未选择的美国人群中巴雷特食管的患病率和风险。这项工作将使提供者能够鉴定出患有巴雷特食管的高风险个体，这是导致食道癌的机场前疾病，并将其纳入内窥镜监测。最终结果将是高度集中的风险分层和预防或通过早期检测改善生存。