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。巴雷特食道是食道衬里的变化，是癌症的前兆。与Barrett‘s食道癌和食管腺癌相关的主要因素是胃灼热和反流，这是胃食道反流病(GERD)的症状。大约20%的美国人每周都有GERD症状，美国每年有超过200万名有GERD症状的成年人接受上消化道内窥镜检查。尽管如此，只有不到15%的食管腺癌患者在确诊前接受过上消化道内窥镜检查。如果有GERD症状的患者对质子泵抑制剂(PPI)反应不充分，则更有可能转诊于上消化道内窥镜检查。大约50%的此类患者没有异常数量的胃食道反流来解释他们的症状，并且经常有以躯体化、焦虑和抑郁为特征的心理困扰。显然，有必要改进内窥镜筛查患者的选择。一种快速、个性化的临床工具已经开发出来，用于识别有巴雷特食道风险的男性，密歇根州巴雷特的食道预测工具(M-BERET)。这项拟议的研究旨在验证这一工具在临床人群中的有效性，将其推广到女性，并确定纳入特定的循环生物标记物和/或心理痛苦特征是否可以提高其准确性。这项研究将招募连续接受首次内窥镜检查的患者，并将该工具的准确性与单独预测Barrett‘s食道的GERD症状的准确性进行比较。还将招募首次接受Barrett‘s食道高度不典型增生或粘膜内癌内窥镜治疗的患者，并将评估该工具的准确性，以区分这些患者和非发育不良Barrett’s患者。 食道，没有巴雷特食道。这项研究还将比较该工具与GERD症状在大型纵向队列中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得到广泛应用，它有望改善内窥镜检查的分配，减少低风险患者的过度使用，增加高危患者的使用，最终有效地减轻食管腺癌的负担。

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.