Minimally Invasive Molecular Approaches for the Diagnosis of Barrett's Esophagus and Esophageal Adenocarcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 1,550
- 试验地点
- 14
- 主要终点
- Aim 3 - Dysplasia Detection Sensitivity and Specificity
研究概览
简要总结
This study will evaluate if the sponge capsule device can accurately detect the presence of Barrett's Esophagus and prevalent dysplasia/adenocarcinoma detection, in a screening population, with and without chronic gastroesophageal reflux disease.
详细描述
The sponge on a string (SOS) device will be safely administered by a non-physician such as a nurse. Novel discriminant methylated DNA markers will be assayed on esophageal cytology specimens obtained from the SOS device to enable detection in Barrett's Esophagus and prevalent dysplasia/adenocarcinoma detection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- 是
入选标准
- •Male and female ages 50-85
- •Patients who have three or more risk factors for Barrett's Esophagus.
- •Gastroesophageal reflux disease defined by:
- •Diagnosis
- •Use of one of the following drugs >= 3 months over the last 5 years: omeprazole, esomeprazole, pantoprazole, rabeprazole, dexlansoprazole, lansoprazole, ranitidine, famotidine, cimetidine
- •prior endoscopic diagnosis of erosive esophagitis
- •Body mass index (BMI) >= 30
排除标准
- •Aim1 and Aim 3:
- •Previous history of:
- •esophageal adenocarcinoma/cancer
- •esophageal squamous carcinoma
- •endoscopic ablation for Barrett's esophagus
- •esophageal squamous dysplasia
- •Current treatment with oral anticoagulation including Warfarin, Coumadin
- •History of cirrhosis
- •History of esophageal/gastric varices
- •History of Barrett's esophagus
- •Prior endoscopy in the last 5 years
- •Inclusion criteria Aim 2 and Aim 3:
- •Subjects with known or suspected BE (cases).
- •Patient between the ages 18 -
- •Patients with a BE segment ≥ 1cm in maximal extent endoscopically or suspected BE in medical record.
- •Histology showing evidence of intestinal metaplasia with or without presence of dysplasia or suspected BE in medical record.
- •Undergoing clinically indicated endoscopy.
- •Subjects without known history of BE (controls).
- •Undergoing clinically indicated diagnostic endoscopy.
- •Exclusion criteria Aim 2:
- •Subjects with known BE.
- •Patients with prior history of ablation (photodynamic therapy, radiofrequency ablation, cryotherapy, argon plasma coagulation). Patients with history of endoscopic mucosal resection (EMR)/endoscopic submucosal dissection (ESD) alone will not be excluded.
- •Patients with history of esophageal resection for esophageal carcinoma.
- •For subjects with or without known evidence of BE (on history or review of medical records):
- •Pregnant or lactating females.
- •Patients who are unable to consent.
- •Patients with current history of uninvestigated dysphagia (this does not apply to the brushings/biopsies only portion of the study).
- •History of eosinophilic esophagitis, achalasia.
- •Patients on oral anticoagulation including Coumadin, Warfarin (this does not apply to the brushings/biopsies only portion of the study).
- •Patients on antiplatelet agents including Clopidogrel, unless discontinued for three to five days prior to the sponge procedure.
- •Patients on oral thrombin inhibitors including Dabigatran and oral factor Xa inhibitors such as rivaroxaban, apixaban and edoxaban, unless discontinued for three to five days prior to the sponge procedure.
- •Patients with history of known esophageal or gastric varices or cirrhosis.
- •Patients with history of surgical esophageal resection for esophageal carcinoma.
- •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.
研究组 & 干预措施
Screening Population
Those that have gastroesophageal reflux or other risk factors for Barrett's Esophagus will be contacted and if agreeable undergo sponge capsule procedure and fill out questionnaires.
干预措施: Sponge Capsule (Device)
Upper endoscopy - Barrett's Esophagus
Those that have a diagnosis of Barrett's Esophagus and are scheduled for an upper endoscopy will be approached and if agreeable undergo sponge capsule procedure as well as endoscopic biopsies and brushings of the esophagus.
干预措施: Sponge Capsule (Device)
Upper endoscopy - No Barrett's Esophagus
Those that have no known Barrett's Esophagus and are scheduled for an upper endoscopy will be approached and if agreeable undergo sponge capsule procedure as well as endoscopic biopsies and brushings of the esophagus.
干预措施: Sponge Capsule (Device)
结局指标
主要结局
Aim 3 - Dysplasia Detection Sensitivity and Specificity
时间窗: 5 years
Measure the sensitivity and specificity of a predetermined MDM panel assayed on SOS specimens from BE patients identified in Aims 1 and 2, for the detection of HGD /EAC, using surveillance histology as the criterion standard.
Aim 1 - Screening Population
时间窗: 5 years
To measure the positive and negative predictive value of the sponge capsule Barrett's esophagus test in a screening population.
Aim 2 - Case/Control Population BE Detection
时间窗: 5 years
Compare the sensitivity and specificity of a predetermined BE prediction algorithm for those with and without GERD and assess the influence of other covariates (age, sex, ever smoking, ethnicity and BMI) on this algorithm.
次要结局
- Aim 2 - Case/Control Population Sensitivity and Specificity(5 years)
- Aim 1 - Screening Population Safety and Tolerability of sponge capsule procedure(5 years)
- Aim 1 - Screening Population Predictive Value(5 years)
- Aim 3 - Dysplasia Detection Rate of Missed Dysplasia(5 years)