A Prospective Clinical Trial to Evaluate Mesothelin as a Biomarker for the Clinical Management of Esophageal Adenocarcinoma (EAC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 371
- 试验地点
- 1
- 主要终点
- To evaluate prospectively what proportion of esophageal adenocarcinomas express tissue.
研究概览
简要总结
The purpose of this study is to find out whether a protein, called mesothelin, found in the blood and tissue can be used as "marker" for esophageal cancer. Doctors at Memorial Sloan-Kettering Cancer Center would like to compare levels of this protein in patients with abnormal cells or tissue of the esophageal to the levels of this protein in patients being treated for cancer for the esophagus.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients with T1 adenocarcinoma or suspected adenocarcinoma who are scheduled for a biopsy and mucosal resection (Group 1)
- •Patients with a T1-2N0 adenocarcinoma or suspected adenocarcinoma who are scheduled to undergo and esophagectomy (Group 2)
- •Patients with T2N1 and T3N0-1 adenocarcinoma or suspected adenocarcinoma who are scheduled to undergo endoscopy and biopsy and/or endoscopic ultrasound and biopsy prior to pre-operative chemo-radiotherapy and have baseline and surgical tissue available for staining (Group 3)
排除标准
- •Patients <18 years of age
- •Patients unfit medically for endoscopy surveillance and therapy
- •Patients unfit medically for esophagectomy
- •Patients with stage IV esophageal adenocarcinoma
- •Patients previously treated with chemo-radiotherapy for their esophageal cancer
- •Patients with squamous cell carcinoma of the esophagus
- •Patients who have a history of cancer within 3 years or have a concurrent cancer.
结局指标
主要结局
To evaluate prospectively what proportion of esophageal adenocarcinomas express tissue.
时间窗: 2 years
The investigators will examine the range and variability in the percentage on cells stained (for TM) and in the absolute value (for SM). TM expression is commonly analyzed in a binary fashion, with 25% of cells stained indicating positive expression (per standard pathological guidelines for tissue staining)
To evaluate prospectively if clinical response to induction chemotherapy
时间窗: 2 years
First, the investigators will use two-sample t-tests to determine whether the initial responders to induction chemotherapy (defined as \>30% decrease in SUV at the repeat PET) differ from non-responders in their 1) baseline (pre-induction) SM value, and 2) percent change in SM value between pre-induction and mid-induction (after 2 cycles) evaluations.
To evaluate prospectively if clinical response to concurrent chemo-radiation correlates to serum mesothelin levels
时间窗: 2 years
The investigators will take the following steps in order to assess the ability of SM at the time of resection with curative intent to predict disease recurrence: 1) we will examine the association between SM and the risk of recurrence by fitting a Cox proportional hazards model (after appropriate transformation of the SM value and checking of the PH assumption
To evaluate prospectively if serum mesothelin levels correlate to clinical stage in esophageal adenocarcinomas
时间窗: 2 years
The investigators will explore the optimal cut point that defines positive expression. Serum mesothelin (SM) will be measured and analyzed whenever possible on a continuous scale.
次要结局
- To evaluate for the presence of any confounders in the putative association between serum mesothelin expression and the risk of recurrence(2 years)
- To evaluate whether expression of tissue mesothelin is a predictor of poor response to chemotherapy(2 years)
- To evaluate the correlation between serum mesothelin levels and tissue expression(2 years)
- To evaluate whether expression of tissue mesothelin is a predictor of recurrence(2 years)