A Novel Strategy for Diagnosis of Esophageal Adenocarcinoma.

食管腺癌的诊断新策略。

• 批准号: 10009836
• 负责人: Daniel Gregory Lunz
• 金额: $ 25.08万
• 依托单位: CAPSULOMICS, LLC
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-06-19 至 2022-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10009836
• 关键词: Address; Barrett Esophagus; Biological Assay; Biological Markers; Biometry; Candidate Disease Gene; Centrifugation; Cessation of life; Clinical; Computer software; Country; DNA; DNA Methylation; Data; Data Set; Deglutition; Detection; Development; Devices; Diagnosis; Diagnostic; Diagnostic tests; Early Diagnosis; Esophageal Adenocarcinoma; Esophagogastroduodenoscopy; Esophagus; Funding; Future; Genes; Goals; Incidence; Lasso; Legal patent; Logistic Regressions; Malignant neoplasm of esophagus; Methods; Methylation; Modeling; Morbidity - disease rate; Oncology; Patients; Phase; Ploidies; Porifera; Precancerous Conditions; Preparation; Procedures; Quality Control; Reproducibility of Results; Research; Sampling; Sensitivity and Specificity; Small Business Technology Transfer Research; Specimen; Speed; Standardization; Statistical Models; Testing; Time; Tissue Sample; Tissues; Training; United States National Institutes of Health; Universities; Validation; Variant; Work; base; biomarker panel; capsule; care costs; design; diagnostic assay; experience; gene panel; improved; medical schools; methylation biomarker; molecular diagnostics; mortality; novel diagnostics; novel strategies; phase 2 study; quality assurance; response; specific biomarkers; tool

Esophageal adenocarcinoma (EAC) is one of two major types of esophageal cancer, which causes 509,000 deaths worldwide annually. EAC diagnosis is made using the invasive, expensive, risky, and not universally accessible procedure, esophagogastroduodenoscopy (EGD). Thus, there is a pressing need for easier, safer, cheaper strategies for EAC diagnosis. Our novel strategy builds on exciting preliminary data in EAC patients involves a swallowable, retrievable sponge capsule device combined with a DNA methylation biomarker panel (JHU patent pending). Capsulomics, a new startup established specifically for this project, will commercialize this diagnostic assay, termed “EsoSAVE,” for EAC detection. This Phase I STTR application contains three Specific Aims to implement this strategy. Aim 1 will optimize and validate the EsophaCap DNA extraction procedure. Aim 2 will generate a multi-parameter statistical model to further strengthen our promising methylation biomarkers. Aim 3 will validate the EsoSAVE test in sponge samples from normal and EAC patients. These Aims will address important scientific questions while simultaneously advancing the EsoSAVE diagnostic test toward commercial implementation.

食管腺癌(EAC)是食道癌的两种主要类型之一，导致50.9万人死亡 全球每年的死亡人数。EAC的诊断是使用侵入性的、昂贵的、有风险的并且不是普遍的 方便的手术，食道胃十二指肠镜(EGD)。因此，迫切需要更容易、更安全、 更便宜的EAC诊断策略。我们的新策略建立在EAC患者令人兴奋的初步数据基础上 涉及一种可吞咽、可回收的海绵胶囊装置与DNA甲基化生物标志物面板相结合 (JHU专利申请中)。一家专门为该项目成立的新创业公司Capsulology将实现商业化 这种诊断分析称为“EsoSAVE”，用于EAC检测。 这一第一阶段STTR应用程序包含三个具体目标，以实施这一战略。目标1将优化 并验证EsophaCap DNA提取程序。目标2将生成一个多参数统计模型 以进一步加强我们前景看好的甲基化生物标志物。AIM 3将在海绵中验证EsoSAVE测试 来自正常人群和EAC患者的样本。这些目标将解决重要的科学问题，同时 同时将EsoSAVE诊断测试推向商业实施。