Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Oncodrivers in Pleural Fluid for NSCLC with Malignant Pleural Effusion

Official title: The Prevalence of Oncodrivers in Malignant Pleural Effusions Associated With Non-small Cell Lung Cancer: A Prospective Study.

Run by Naestved Hospital · NCT04806412 · Data updated 2026-11-12

This study tests whether PD-L1, ALK, and EGFR can be detected in pleural fluid from NSCLC patients with malignant effusion to see how common these oncodriver markers are.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment100 (estimated)
SponsorNaestved Hospital
Academic / other
Locations1 site (Næstved, Region Sjælland)
StatusRecruiting
StartedMarch 15, 2021
Main results expectedDecember 31, 2028
Study endsDecember 31, 2028
Registry record updatedJune 24, 2026
Trial IDNCT04806412 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults 18 years or older with pleural effusion cytology positive for NSCLC and able to consent.

Probably not a fit

Patients in whom pleural fluid does not reveal any oncodriver status or for whom testing is not feasible may not benefit from this approach.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, non-randomized, cohort study conducted at regional pleural clinics. Researchers will measure PD-L1, ALK, and EGFR in pleural fluid samples from adults with NSCLC-related pleural effusion to determine the prevalence of oncodriver status. The analysis will also explore whether the amount of fluid tested affects the likelihood of detecting oncodrivers and how absence of these markers might influence subsequent diagnostic work-up. Follow-up occurs 8 weeks after enrollment to monitor initial clinical status. Eligible participants include adults with pleural effusion suspected or known to be associated with NSCLC, who can provide informed consent, excluding those without any oncodriver data available in current work-up or who cannot understand Danish.

Why it matters

Potential benefit: If successful, the study could clarify how often key molecular targets are detectable in pleural fluid, potentially guiding future diagnostic and treatment decisions.

How similar studies have gone: Previous efforts in molecular testing of pleural fluid have shown variable yields; this study aims to quantify prevalence in a prospective cohort.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Age ≥ 18 years
* Pleural effusion known or suspected of association with NSCLC (pleural fluid cytology positive for cells from NSCLC)
* Patients must be able to give informed consent

Exclusion Criteria:

* Full oncodriver status measured in any pleural fluid in current work-up
* Inability to understand written or spoken Danish.

Where it's running

  • Næstved Sygehus, department of pulmonary medicine
    Næstved, Region Sjælland, Denmark
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.