Validation and Extension of the Michigan Barretts Esophagus pREdiction Tool (M-BERET)

描述（由申请人提供）： 在过去的40年里，美国食管腺癌的发病率上升了6倍。巴雷特食管是食管内壁的变化，是癌症的前兆。与巴雷特食管和食管腺癌相关的主要因素是胃灼热和反流，这是胃食管反流病（GERD）的症状。大约20%的美国人每周都会出现GERD症状，在美国每年有超过200万例上消化道内镜检查在有GERD症状的成年人中进行。尽管如此，只有不到15%的食管腺癌患者在诊断癌症之前进行了上消化道内窥镜检查。如果质子泵抑制剂（PPI）对GERD症状反应不充分，则GERD症状患者更有可能接受上消化道内镜检查。大约50%的此类患者没有异常量的胃食管反流占他们的症状，往往有心理困扰的特征是躯体化，焦虑和抑郁。显然，有必要改进内窥镜筛查患者的选择。一种快速，个性化的临床工具，用于识别男性巴雷特食管的风险已经开发出来，密歇根州巴雷特食管预测工具（M-BERET）。这项拟议的研究旨在在临床人群中验证该工具，将其扩展到女性，并确定纳入特定的循环生物标志物和/或心理困扰特征是否可以提高其准确性。该研究将招募连续患者进行首次内窥镜检查，并比较该工具与单独GERD症状预测Barrett食管存在的准确性。还将入组首次内镜治疗Barrett食管高度异型增生或粘膜内癌的患者，并评估该工具的准确性，以区分这些患者与非异型增生Barrett食管患者。 食管而不是巴雷特食管该研究还将在一个大型回顾性纵向队列中比较该工具对GERD症状预测食管腺癌发病率的准确性。如果个性化工具在拟议的研究中得到验证并广泛使用，预计将改善内镜检查的分配，减少低风险患者的过度使用，增加高风险患者的使用，最终以有效的方式降低食管腺癌的负担。

DESCRIPTION (provided by applicant): The incidence of esophageal adenocarcinoma in the United States has risen 6-fold over the last 4 decades. Barrett's esophagus is a change in the lining of the esophagus that is a precursor to the cancer. Major factors associated with both Barrett's Esophagus and esophageal adenocarcinoma are heartburn and regurgitation, which are symptoms of gastroesophageal reflux disease (GERD). Roughly 20% of Americans have GERD symptoms on a weekly basis, and over 2 million upper endoscopies are performed annually in the U.S. in adults with GERD symptoms. Nonetheless, fewer than 15% of patients with esophageal adenocarcinoma have had an upper endoscopy prior to their diagnosis of the cancer. Patients with GERD symptoms are more likely to be referred to upper endoscopy if their symptoms have responded inadequately to proton pump inhibitors (PPIs). Approximately 50% of such patients do not have abnormal amounts of gastroesophageal reflux accounting for their symptoms, and often have psychological distress characterized by features of somatization, anxiety and depression. Clearly, there is a need for improved selection of patients for endoscopic screening. A quick, personalized clinical tool for identifying men at risk for Barrett's esophagus has been developed, the Michigan Barrett's Esophagus pREdiction Tool (M-BERET). The proposed study aims to validate that tool in a clinical population, extend it to women, and to determine if inclusion of specific circulating biomarkers and/or features of psychological distress can improve its accuracy. The study will enroll consecutive patients undergoing their first endoscopy and compare the accuracy of the tool to GERD symptoms alone for predicting the presence of Barrett's esophagus. Patients referred for their first endoscopic treatment of Barrett's esophagus with high grade dysplasia or intramucosal cancer will also be enrolled, and the accuracy of the tool will be assessed for discriminating these patients from patients with non-dysplastic Barrett's esophagus and no Barrett's esophagus. The study will also compare the accuracy of the tool to GERD symptoms for predicting the incidence of esophageal adenocarcinoma in a large retrospective longitudinal cohort. If the personalized tool is validated in the proposed study and widely used, it is expected to improve the allocation of endoscopy, decreasing over-utilization in low-risk patients, and increasing utilization in high-risk patients, ultimately decreasing the burden of esophageal adenocarcinoma in an efficient manner.