Minimally Invasive Molecular Approaches for the Detection of Barrett's Esophagus- High Grade Dysplasia and Esophageal Adenocarcinoma- Renewal Grant Aim 2 (The SOS6C Trial)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Mayo Clinic
- 入组人数
- 450
- 试验地点
- 6
- 主要终点
- Sensitivity of deoxyribonucleic acid (DNA) markers
研究概览
简要总结
This study explores the use of a minimally invasive screening tool (a sponge on a string device) to detect Barrett's esophagus and esophageal adenocarcinoma and to develop a laboratory test for the detection of Barrett's esophagus-high grade dysplasia and esophageal adenocarcinoma.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient between the ages 18 - 90
- •Patients with a BE segment >= 1cm in maximal extent endoscopically
- •Histology showing evidence of intestinal metaplasia with or without presence of dysplasia
- •Undergoing clinically indicated endoscopy
排除标准
- •Patients with a prior history of ablation (photodynamic therapy, radiofrequency ablation, cryotherapy, argon plasma coagulation). Patients with a history of endoscopic mucosal resection alone will not be excluded
- •Patients with a history of esophageal or gastric resection for esophageal or gastric carcinoma
- •Subjects with known evidence of BE (on history or review of medical records)
- •Pregnant or lactating females
- •Patients who are unable to consent
- •Patients with a current history of uninvestigated dysphagia (this does not apply to the brushings/biopsies only portion of the study for RST/ARZ sites only)
- •History of eosinophilic esophagitis or achalasia
- •Patients on oral anticoagulation including Coumadin, and warfarin, unless discontinued for thee to five days prior to the sponge procedure. (This does not apply to the brushing/biopsy only portion of the study for RST/ARZ sites only)
- •Patients on antiplatelet agents including clopidogrel, unless discontinued for three to five days prior to the sponge procedure. (This does not apply to the brushing/biopsy only portion of the study for RST/ARZ sites only)
- •Patients on oral thrombin inhibitors including dabigatran and oral factor X an inhibitor such as rivaroxaban, apixaban, and edoxaban, unless discontinued for three to five days prior to the sponge procedure. (This does not apply to the brushing/biopsy only portion of the study for RST/ARZ sites only)
- •Patients with a history of known esophageal or gastric varices or cirrhosis
- •Patients with a history of esophageal or gastric resection
- •Patients with congenital or acquired bleeding diatheses
- •Patients with a history of esophageal squamous dysplasia
- •Patient has known carcinoma of the foregut (pancreatic, bile duct, ampullary, stomach, or duodenum) within 5 years prior to study enrollment
- •Patient has received chemotherapy class drugs or radiation to treat mediastinal or esophageal cancer
- •Patients with Familial Adenomatous Polyposis (FAP) or Lynch Syndrome
研究组 & 干预措施
Observational
Patients undergo capsule sponge assessment over 5-10 minutes prior to standard of care endoscopy. Patients also undergo biopsy and esophageal brushing sample collection and complete questionnaires on study.
干预措施: Non-Interventional Study (Other)
结局指标
主要结局
Sensitivity of deoxyribonucleic acid (DNA) markers
时间窗: Baseline
Will evaluate the sensitivity of DNA makers (methylated DNA markers ± aneuploidy) to distinguish between high-grade dysplasia (HGD)/esophageal adenocarcinoma (EAC) and non-dysplastic Barrett's esophagus (BE).
Specificity of DNA markers
时间窗: Baseline
Will evaluate the specificity of DNA markers (methylated DNA markers ± aneuploidy) to distinguish between HGD/EAC and non-dysplastic BE.
次要结局
未报告次要终点