Esophageal Cancer (10030139, 10066354) Screening With FISH in Esophageal Cytology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Sensitivity of Sponge Cytology Using FISH
研究概览
简要总结
This clinical trial studies whether esophageal cytology plus fluorescence in situ hybridization (FISH) is equal to or better than esophago-gastro-duodenoscopy (EGD) or upper endoscopy for the early detection of esophageal cancer. Genes are the units of deoxyribonucleic acid (DNA) the chemical structure carrying genetic information that determine many human characteristics. Certain genes in cancer cells may determine how the tumor grows or spreads and how it may respond to different drugs. Part of this study is to test those genes in esophageal cells using FISH.
详细描述
PRIMARY OBJECTIVES:
I. Determine if sponge cytology with FISH is a reliable screening tool for esophageal dysplasia/cancer, and determine its sensitivity and specificity, compared to the gold standard procedure (upper endoscopy).
SECONDARY OBJECTIVES:
I. Determine if the cytology screening with FISH biomarkers is more cost effective than upper endoscopy for the screening of esophageal cancer and the surveillance of esophageal metaplasia and dysplasia.
II. Determine the limitations and future needs to improve this technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- 是
入选标准
- •Subjects with known esophageal cancer diagnosed by previous endoscopy
- •Adenocarcinoma
- •Squamous cell carcinoma
- •Patients determined to be at risk for esophageal cancer:
- •Subjects with a history of Barrett's esophagus
- •Subjects with a history of low or high grade dysplasia
- •Subjects with a history of gastroesophageal reflux disease (GERD)
- •Subjects with a history of esophagitis
- •Subjects with symptoms of esophageal cancer (EC) referred for endoscopy (new onset dysphagia, weight loss, etc)
- •Patients must be scheduled for a procedure capable of providing a definitive pathological diagnosis and evaluating for complications of the esophageal sponge on the same day as the study procedure, either:
- •Upper endoscopy
- •Surgical esophagectomy
- •Subjects with Eastern Cooperative Oncology Group (ECOG) performance status =< 3 (Karnofsky >= 30%) will be included
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •Subjects with severe, symptomatic dysphagia (unable to pass solids)
- •Subjects that are unable to swallow a tablet/pill for any reason
- •Subjects with a previous esophagectomy
- •Subjects with esophageal varices
- •Subjects unable to provide consent
- •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
结局指标
主要结局
Sensitivity of Sponge Cytology Using FISH
时间窗: At the time of sponge cytology and EGD
All processed (FISH) esophageal cells will be compared to the final pathologic esophageal diagnoses determined by EGD or surgical resection to assess the test's sensitivity and specificity for the diagnosis of esophageal cancer. Using EGD diagnostic outcomes as the gold standard, the sensitivity and specificity will be computed with corresponding 95% confidence interval of the FISH sponge cytology test in the study population.
Specificity of Sponge Cytology Using FISH
时间窗: At the time of sponge cytology and EGD
All processed (FISH) esophageal cells will be compared to the final pathologic esophageal diagnoses determined by EGD or surgical resection to assess the test's sensitivity and specificity for the diagnosis of esophageal cancer. Using EGD diagnostic outcomes as the gold standard, the sensitivity and specificity will be computed with corresponding 95% confidence interval of the FISH sponge cytology test in the study population.
次要结局
- Adverse Events Associated With FISH Sponge Cytology Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0(At the time of sponge cytology procedure)
- Tolerability of FISH Spongy Cytology(After completion of FISH and EGD)
研究者
John Hunter
Interim Dean
OHSU Knight Cancer Institute