Next Generation Sequencing of Esophageal Cytology for the Early Detection of Esophageal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Detection of gene mutations using next generation sequencing (NGS)
研究概览
简要总结
This pilot clinical trial studies how well a swallowable sponge cell sampling device and next generation sequencing work in detecting esophageal cancer in patients with low or high grade dysplasia, Barrett esophagus, or gastroesophageal reflux disease. Checking biomarkers in abnormal esophageal cells using a swallowable sponge cell sampling device and next generation sequencing may improve diagnosis and treatment of esophageal cancer.
详细描述
PRIMARY OBJECTIVES:
I. Determine the sensitivity and specificity of next generation sequencing for the detection of esophageal cancer from esophageal sponge cytology specimens.
SECONDARY OBJECTIVES:
I. Determine the ability of next generation gene sequencing (NGS) of esophageal sponge samples to collect an adequate sample to detect mutations that are present in the underlying tissue.
II. Determine the cost associated with esophageal cytology with next generation genome sequencing as a screening tool.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to understand and the willingness to sign a written informed consent document
- •Patients must be scheduled for a procedure capable of providing a definitive pathologic diagnosis and evaluating for complications of the esophageal sponge on the same day as the study procedure, either upper endoscopy or surgical esophagectomy
- •One of the following inclusion criteria must be true for patient to be eligible for enrollment:
- •Subjects with known esophageal cancer (adenocarcinoma or squamous cell carcinoma)
- •Subjects with a history of low or high grade dysplasia
- •Subjects with risk factors for esophageal malignancy including Barrett?s esophagus and gastroesophageal reflux disease (GERD)
排除标准
- •Subjects that are unable to swallow a tablet/pill
- •Subjects with completely obstructing esophageal cancer
- •Subjects with known or suspected esophageal varices
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Any condition which, in the opinion of the investigator precludes the patient from completion of the study procedure
结局指标
主要结局
Detection of gene mutations using next generation sequencing (NGS)
时间窗: Up to 2 years
Will calculate the concordance of the gene mutations identified from the sponge sample to those identified from the tissue biopsy (control).
次要结局
- Sensitivity and specificity of the NGS probes to detect underlying esophageal dysplasia or cancer(Up to 2 years)