Assessment of a Minimally Invasive Collection Device for Molecular Analysis of Esophageal Samples for the Non-endoscopic Detection of Barrett's Esophagus With and Without Dysplasia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 450
- 试验地点
- 10
- 主要终点
- DNA yield from esophageal cytology samples collected with the Cytosponge device
研究概览
简要总结
This clinical trial evaluates the use of cytosponge, a minimally invasive collection device, for the detection of Barrett's esophagus (BE) in patients undergoing endoscopy. Non-endoscopic swallowable encapsulate sponge cell collection devices combined with markers for BE/esophageal adenocarcinoma (EAC) detection are a guideline-endorsed alternative to endoscopy for BE screening. The Oncoguard registered trademark Esophagus test (OGE) test uses esophageal cytology specimens collected with a minimally invasive, non-endoscopic, encapsulated sponge sampling device to identify BE/EAC biomarkers that indicate whether a patient should undergo diagnostic endoscopy. The OGE test is a simple and cost effective screening method that may lower barriers to widespread adoption of BE screening in at risk patients, resulting in increased and earlier detection of BE/EAC.
详细描述
PRIMARY OBJECTIVES:
I. Measure Deoxyribonucleic acid (DNA) yield from esophageal cytology samples collected with the Cytosponge device.
II. Evaluate the methylated DNA markers (MDM) levels and accuracy of the Oncoguard Esophagus test (OGE test) for the detection of methylated DNA markers in Cytosponge collected esophageal cytology samples.
SECONDARY OBJECTIVES:
I. Assess the tolerability of the Cytosponge device using a tolerability questionnaire II. Evaluate presence of any trauma to the esophagus from the passage of the Cytosponge device using the endoscopic injury score.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 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
- 否
入选标准
- •Subjects with known or suspected Barrett's esophagus (BE) (cases)
- •Patients between the ages of 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
排除标准
- •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.
- •History of eosinophilic esophagitis, achalasia.
- •Patients on oral anticoagulation including Coumadin, Warfarin.
- •Patients on antiplatelet agents including Clopidogrel, unless discontinued for three to five days prior to the Cytosponge 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 Cytosponge 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
Known or Suspected Barrett's Esophagus (Case Arm)
Investigators will follow Cytosponge Cell Collection Kit Instructions for Use to administer and retrieve the Cytosponge device.c. After the sponge is retrieved, it will then be placed in a vial of cell preservative solution (PN DD-13631, Exact Sciences, Madison, WI) and shipped to the Exact Sciences laboratory for further processing and subsequent analysis.
干预措施: Cytosponge Procedure (Device)
Known or Suspected Barrett's Esophagus (Case Arm)
Investigators will follow Cytosponge Cell Collection Kit Instructions for Use to administer and retrieve the Cytosponge device.c. After the sponge is retrieved, it will then be placed in a vial of cell preservative solution (PN DD-13631, Exact Sciences, Madison, WI) and shipped to the Exact Sciences laboratory for further processing and subsequent analysis.
干预措施: Endoscopic Assessment (Diagnostic Test)
No Known Barrett's Esophagus (Control Arm)
Participants will undergo a diagnostic clinically indicated sedated endoscopy with standard endoscopic equipment.
干预措施: Cytosponge Procedure (Device)
No Known Barrett's Esophagus (Control Arm)
Participants will undergo a diagnostic clinically indicated sedated endoscopy with standard endoscopic equipment.
干预措施: Endoscopic Assessment (Diagnostic Test)
结局指标
主要结局
DNA yield from esophageal cytology samples collected with the Cytosponge device
时间窗: 12 months
DNA concentration from samples collected with the Cytosponge device will be compared with DNA concentration previously observed from samples collected with the EsophaCap device on another study. The DNA concentration range for EsophaCap collected specimens ranged from 0.4 to 285ng/uL.
Accuracy of the Oncoguard Esophagus (OGE) test
时间窗: 12 months
Methylated DNA marker (MDM) levels and accuracy (sensitivity and specificity) will be evaluated to determine the accuracy of the OGE test using Cytosponge-collected esophageal samples. Accuracy will be established using upper endoscopy with pathology confirmed histology as the criterion standard for the diagnosis of Barrett's Esophagus (BE). The recently established algorithm for defining the OGE test as positive or negative (from EsophaCap samples collected from another study) will be utilized to adjudicate the Cytosponge samples as positive or negative. Accuracy of the OGE test for the Cytosponge device will be assessed in relation to the estimates and confidence intervals previously observed.
次要结局
- Tolerability of the Cytosponge device(7 days)
- Trauma to the esophagus from the passage of the Cytosponge device(7 days)