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

密歇根巴雷特食管预测工具 (M-BERET) 的验证和扩展

• 批准号: 9001810
• 负责人: JOEL H RUBENSTEIN
• 金额: --
• 依托单位: VETERANS HEALTH ADMINISTRATION
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-01-01 至 2018-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9001810
• 关键词: Accounting; Adult; Age; American; Anxiety; Barrett Esophagus; Central obesity; Cigarette; Clinical; Colon Carcinoma; Colonoscopy; Consensus; Development; Diagnosis; Discrimination; Dysplasia; Endoscopy; Enrollment; Esophageal; Esophageal Adenocarcinoma; Esophagogastroduodenoscopy; Esophagus; Frequencies; Funding; Future; Gastroenterologist; Gastroesophageal reflux disease; Goals; Guidelines; Heartburn; Incidence; Individual; Interleukin-6; Leptin; Lesion; Malignant Neoplasms; Malignant neoplasm of esophagus; Mental Depression; Mentored Patient-Oriented Research Career Development Award; Michigan; Modeling; National Institute of Diabetes and Digestive and Kidney Diseases; Neoplasms; Obesity; Patient Selection; Patient risk; Patients; Population; Premalignant; Probability; Proton Pump Inhibitors; Recommendation; Recruitment Activity; Research; Research Personnel; Retrospective Studies; Risk; Risk Factors; Symptoms; Tobacco; Tobacco use; United States; Validation; Veterans; Waist-Hip Ratio; Woman; Work; base; cancer diagnosis; circulating biomarkers; cohort; cost; cost effective; ghrelin; high risk; improved; male; medical specialties; men; mortality; neoplastic; patient population; personalized approach; psychological distress; public health relevance; response; screening; sex; tool

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.

描述（由申请人提供）： 在过去的40年中，美国食管腺癌的发生率已增加6倍。巴雷特的食道是食道壁层的变化，这是癌症的前体。与巴雷特的食道和食道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。大约有20％的美国人每周患有GERD症状，并且在患有GERD症状的成年人中，每年在美国进行超过200万个上镜下。但是，在诊断出癌症之前，只有不到15％的食管腺癌患者患有上镜检查。如果患有GERD症状的患者对质子泵抑制剂（PPI）的反应不足，则更有可能被转移到上内窥镜检查中。大约50％的此类患者没有异常数量的胃食管反流，以解决其症状，并且通常具有躯体化，焦虑和抑郁症的特征的心理困扰。显然，需要改善患者的内窥镜检查。密歇根州巴雷特的食道预测工具（M-Beret），已经开发了一种快速，个性化的临床工具，用于识别有巴雷特食管风险的男性。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，并确定包含特定的循环生物标志物和/或心理困扰的特征是否可以提高其准确性。该研究将招募连续接受其首次内窥镜检查的患者，并将工具的准确性与仅GERD症状进行比较，以预测Barrett食管的存在。还将招募对Barrett食管的首次内窥镜治疗，患有高级发育不全或粘膜内癌症的患者，该工具的准确性将被评估，以将这些患者与非抑制性Barrett的患者区分开来。 食道和无巴雷特的食道。该研究还将将工具的准确性与GERD症状进行比较，以预测大型回顾性纵向纵向队列中食管腺癌的发生率。如果在拟议的研究中对个性化工具进行了验证并广泛使用，则预计将改善内窥镜的分配，减少低风险患者的过度利用，并增加高危患者的利用率，最终减轻食管腺癌的负担。