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A Study to Establish the Diagnostic Value of the EPISEEK-MPE Liquid Biopsy Assay to Identify Cancer in Pleural Effusion Samples. (EPISEEK-MPE)

2026年11月5日更新者：Billie Bixby、University of Arizona

Development of a Molecular Assay to Diagnose Malignant Pleural Effusions

The goal of this study is to evaluate the EPISEEK-MPE laboratory test for diagnosis of malignant (cancerous) pleural effusions verses pleural effusions caused by a non-cancer condition. The study uses excess samples drained from around the lung as part of a patient's regular care. The main questions the study aims to answer are:

Is the EPISEEK-MPE test reliable to detect cancer cells and aid in the diagnosis of malignant pleural effusions?
Do age, race, gender and ethnicity change the reliability of the EPISEEK-MPE test?
Can the results of the EPISEEK-MPE test predict which patients have a better chance of survival than others?

Participants will be asked to donate a small portion of the excess fluid drained from around the lung for research. Participants will also give permission to collect data from the medical records.

研究概览

地位

招聘中

条件

胸腔积液

详细说明

In clinical practice, it remains a challenge to distinguish between malignant pleural effusion (MPE) and benign pleural effusion (BPE). Because of the limitations of conventional cytology methods, there is an urgent need to develop a more accurate and effective method for the efficient diagnosis of MPE. In collaboration with the University of Arizona, Precision Epigenomics has developed the EPISEEK-MPE test that has the potential to be an effective complimentary tool for cytology in the process of differential diagnosis. The aim of this project is to conduct a multi-site clinical validation study to establish the EPISEEK-MPE test as a new commercial molecular test for the diagnosis of malignant pleural effusions. The study will: 1) Establish the diagnostic value of the EPISEEK_MPE liquid biopsy assay to identify cancer in pleural effusion and 2) Validate the EPISEEK-MPE liquid biopsy assay for cancer detection in pleural effusion. The long-term goal of this project is to bring the field of pathology a new diagnostic tool for the diagnosis of malignant pleural effusions.

研究类型

观察性的

注册 (估计的)

625

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

美国
- Arizona
  - Tucson、Arizona、美国、85713
    - 招聘中
    - Banner University Medical Center South
    - 接触：
      
      Trina Hughes
      
      电话号码：520-626-9372
      
      邮箱：tdhughes@arizona.edu
  - Tucson、Arizona、美国、85719
    - 招聘中
    - Banner University Medical Center Tucson
    - 接触：
      
      Trina Hughes
      
      电话号码：520-626-9372
      
      邮箱：tdhughes@arizona.edu

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Adult patients that are having pleural fluid drained as part of clinical care.

描述

Inclusion Criteria:

Adult patients having pleural fluid drained for clinical care (thoracentesis or chest tube placement)
Consent to have pleural fluid sample used for research

Exclusion Criteria:

- Insufficient fluid available following clinical drainage procedure

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

观测模型：COHORT
时间观点：PROSPECTIVE

团体/队列数

队列和干预

团体/队列
Benign pleural effusions Patients with pleural effusions due to infection, heart failure, atelectasis, bronchial obstruction, pulmonary embolism, etc. To be included in the benign group, subjects cannot have any cancer-related history within the last 15 years and chest radiograph will be without evidence of lung mass / malignancy.
Indeterminate pleural effusions Patients with a known cancer diagnosis, but with cytology negative pleural fluid.
Malignant pleural effusions Patients with known cancer and a cytology positive pleural fluid sample.

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Diagnostic performance 大体时间：From enrollment to the completion of the study analysis an average of 2 years	To determine the diagnostic performance characteristics of the EPISEEK-MPE test in terms of accuracy, specificity, sensitivity, negative predictive value (NPV), and positive predictive value (PPV).	From enrollment to the completion of the study analysis an average of 2 years
Predictive value 大体时间：From enrollment to 1 year post procedure	Investigators will evaluate the association of the methylation signal from the EPISEEK-MPE test with overall survival.	From enrollment to 1 year post procedure
Validate EPISEEK-MPE 大体时间：From enrollment to the completion of the study analysis	Establish the performance specifications of EPISEEK-MPE as a laboratory developed test including: Reportable range Analytical sensitivity Precision Analytical specificity Accuracy Reference interval	From enrollment to the completion of the study analysis

次要结果测量

结果测量	措施说明	大体时间
Methylation signal 大体时间：At baseline	Determine the methylation signal relationship with clinical variables such as age, race, gender, and ethnicity.	At baseline

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Arizona

合作者

National Cancer Institute (NCI)

Precision Epigenomics

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年1月8日

初级完成 (估计的)

2026年12月31日

研究完成 (估计的)

2027年5月1日

研究注册日期

首次提交

2026年5月8日

首先提交符合 QC 标准的

2026年11月5日

首次发布 (实际的)

2026年11月10日

研究记录更新

最后更新发布 (实际的)