A Study to Establish the Diagnostic Value of the EPISEEK-MPE Liquid Biopsy Assay to Identify Cancer in Pleural Effusion Samples.
Pleural Effusions
What this study involves
The registry says this study is recruiting. Individual locations may have different availability.
- Study type
- Observational
- Phase
- Not applicable / not listed
- Age range
- 18 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 625 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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:
1. Is the EPISEEK-MPE test reliable to detect cancer cells and aid in the diagnosis of malignant pleural effusions?
2. Do age, race, gender and ethnicity change the reliability of the EPISEEK-MPE test?
3. 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.
Read the full description
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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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
Study population
Adult patients that are having pleural fluid drained as part of clinical care.
Understand screeningTreatment, groups and participation
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- Assignment
- Not reported
- Masking
- Not reported
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.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Diagnostic performance
Time frame: 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).
Predictive value
Time frame: From enrollment to 1 year post procedure
Investigators will evaluate the association of the methylation signal from the EPISEEK-MPE test with overall survival.
Validate EPISEEK-MPE
Time frame: From enrollment to the completion of the study analysis
Establish the performance specifications of EPISEEK-MPE as a laboratory developed test including:
1. Reportable range
2. Analytical sensitivity
3. Precision
4. Analytical specificity
5. Accuracy
6. Reference interval
Secondary measures
Methylation signal
Time frame: At baseline
Determine the methylation signal relationship with clinical variables such as age, race, gender, and ethnicity.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (2)
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2 locations
Banner University Medical Center SouthTucson, Arizona, United StatesRecruiting
Banner University Medical Center TucsonTucson, Arizona, United StatesRecruiting
Study team and timeline
- Lead sponsor
- University of Arizona
- Study start
- Jan 8, 2025 Actual
- Primary completion
- Dec 31, 2026 Estimated
- Study completion
- 2027-05 Estimated
- First posted
- Nov 10, 2026 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study title
Development of a Molecular Assay to Diagnose Malignant Pleural Effusions
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026