Prospectively Collected Pleural Biopsies for Validation of Malignant Pleural Mesothelioma Prognostic Biomarkers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Pre-treatment Prognostic Algorithm Validation
研究概览
简要总结
This research study is evaluating a new method for determining stage and prognosis of individuals with malignant pleural mesothelioma.
详细描述
The purpose of this research study is to test a new method for determining the stage and prognosis of patients with malignant pleural mesothelioma. Currently, it is not possible to accurately determine cancer stage prior to surgery or another treatment. This new method may allow doctors to better classify cancer stage and give a better estimate for prognosis prior to surgery or another treatment.
In this research study, the investigators would like to use biopsied tissue to study certain characteristics that will help test the new method for determining cancer stage and estimating prognosis.
In this research study, the investigators are...
- Obtaining pleural specimens at the time of routine diagnostic biopsy during the participant's standard treatment.
- Storing your biopsied tissue
- Studying the tissue to determine if the new method of staging and prognosis is accurate and valid
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •All adult patients with a diagnosis of malignant pleural mesothelioma undergoing
- •diagnostic pleural biopsy
- •pleuroscopy
- •and/or VATS resections
- •Participants must be 18 years of age or older.
排除标准
- •Any patient who is found to be unsuitable for
- •treatment
- •diagnosis,
结局指标
主要结局
Pre-treatment Prognostic Algorithm Validation
时间窗: 4 years
The primary objective is to utilize a novel prognostic algorithm to predict the outcome of MPM patients. This algorithm includes 4 different tests: molecular, radiological, and blood based. It will be performed on 240 prospectively-collected samples. A score of 0-4 will be assigned to each patient and the data will be analyzed by a statistician
次要结局
- Evaluation of Molecular Tests Base on RNA Expression(4 years)
研究者
Raphael Bueno, MD
Principal Investigator
Dana-Farber Cancer Institute