NCT02066701已完成不适用
Utility of Aberrant Gene Methylation in the Diagnosis of Barrett's Esophagus: Identification of Candidate Diagnostic Markers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- to determine if assay of aberrantly methylated gene markers can discriminate Barrett's Esophagus tissue (and presence of dysplasia) from esophageal squamous and gastric cardia tissue.
研究概览
简要总结
This study is to identify potential markers from esophageal biopsies and brush cytology for feasibility of use in stool specimens for detection of Barretts Esophagus.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Controls: No endoscopic evidence of Barrett's Esophagus, able to give informed consent, 18 years of age or older.
- •Cases: At least 1 cm of visible columnar epithelium with intestinal metaplasia on histology confirmed by an expert GI pathologist (on biopsy), able to give informed consent, 18 years of age or older.
- •Exclusion criteria:
- •Controls: Patients with history of esophagectomy or mucosal ablation, gastrectomy, or known non-Barrett's esophageal pathology (e.g. eosinophilic esophagitis or achalasia), varices, esophagitis LA Grade B, C, D will be excluded. Patients with prior history of colon polyps or colon/esophageal/gastric/pancreatic carcinoma (unless had negative colonoscopy within 2 years to clear polyps).
- •Cases: Patients with history of esophagectomy or mucosal ablation, gastrectomy, or known non-Barrett's esophageal pathology (e.g. eosinophilic esophagitis or achalasia), will be excluded. Patients with prior history of colon polyps or colon/gastric/pancreatic carcinoma (unless had negative colonoscopy within 2 years to clear polyps).
排除标准
- 未提供
结局指标
主要结局
to determine if assay of aberrantly methylated gene markers can discriminate Barrett's Esophagus tissue (and presence of dysplasia) from esophageal squamous and gastric cardia tissue.
时间窗: 1 day
we will plan to identify the best markers from highly selected marker candidates to differentiate between subjects who have BE and those who do not have BE.
次要结局
- Assess the accuracy of candidate markers in stool for detection of Barrett's Esophagus(One day)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
DNA Methylation Analysis in Acute Coronary Syndrome and Atrial Fibrillation: DIANA Clinical TrialAtrial FibrillationAcute Coronary SyndromeCoronary Artery DiseaseNCT04371809University of Campania "Luigi Vanvitelli"100
招募中
不适用
Evaluation of DNA Methylation Signatures for the Diagnosis and Management of Thyroid NodulesThyroid Gland CarcinomaNCT05229341City of Hope Medical Center1,450
招募中
不适用
Immunohistochemical Evaluation of DNA Methylation and Histone Modification in H. Pylori Associated Gastric CarcinomaGastric CarcinomaNCT05811546Assiut University68
Unknown
不适用
Validation of DNA Methylation Biomarkers for Oral Cancer Detection-Follow up StudyOral CancerNCT02902406National Taiwan University Hospital300
进行中（未招募）
不适用
Clinical Utility of Methylation-based Prognostic Assay for Barrett's EsophagusBarrett EsophagusEsophageal CancerNCT05846971Capsulomics, Inc.100