Recruiting

EPISEEK-MPE

Sponsor:

University of Arizona

Code:

NCT07929584

Conditions

Pleural Effusions

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Pleural Effusions

Study ID

NCT07929584

Start date

Jan 8, 2025

Status verified date

Nov, 2026

Completion date

May, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

625 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Diagnostic performance [ Time Frame: 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 ]
  • Validate EPISEEK-MPE [ Time Frame: From enrollment to the completion of the study analysis ]

Central Contacts and Locations

Locations

Banner University Medical Center South

Recruiting

Tucson, Arizona, United States, 85713

Contacts

Trina Hughes

520-626-9372tdhughes@arizona.edu

Banner University Medical Center Tucson

Recruiting

Tucson, Arizona, United States, 85719

Contacts

Trina Hughes

520-626-9372tdhughes@arizona.edu

More Information

Sponsor

University of Arizona

Last update posted

Nov 10, 2026

Last verified

Nov, 2026

Keywords

  • pleural effusion
  • DNA methylation
  • malignant pleural effusion
  • benign pleural effusion
  • indeterminate pleural effusion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-11. This information was provided to ClinicalTrials.gov by University of Arizona on 2026-11-10. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.