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

November 5, 2026 updated by: 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:

  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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
625

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85713
        • Recruiting
        • Banner University Medical Center South
        • Contact:
      • Tucson, Arizona, United States, 85719
        • Recruiting
        • Banner University Medical Center Tucson
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: COHORT
  • Time Perspectives: PROSPECTIVE

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
From enrollment to the completion of the study analysis an average of 2 years
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.
From enrollment to 1 year post procedure
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
From enrollment to the completion of the study analysis

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Methylation signal
Time Frame: At baseline

Determine the methylation signal relationship with clinical variables such as age, race, gender, and ethnicity.
At baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Arizona

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)
Precision Epigenomics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 8, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 8, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB # 2012283169
  • 1R44CA287829-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This is an exploratory study with a commercial entity and data is considered joint intellectual property.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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