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 type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Naestved Hospital Academic / other |
| Locations | 1 site (Næstved, Region Sjælland) |
| Status | Recruiting |
| Started | March 15, 2021 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | June 24, 2026 |
| Trial ID | NCT04806412 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
- Study coordinator: Katrine Fjaellegaard, MD
- Email: kafj@regionsjaelland.dk
- Phone: 31924375
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Patient-specific MRD liquid biopsy for resected NSCLC
This study tests a personalized MRD blood and bronchial washing test after surgery to see if it can signal recurrence earlier in people with resected NSCLC.
-
Osimertinib Plus SRS/SRT for EGFR-Mutant NSCLC with Symptomatic Brain Metastases
This study tests whether adding targeted brain radiotherapy to osimertinib helps control brain metastases in adults with EGFR-mutant NSCLC and neurological symptoms.
-
Dato-DXd in solid tumors (Urothelial Cancer and KRAS-mutant NSCLC) in two sub-studies
This study tests Datopotamab Deruxtecan (Dato-DXd) alone or with other cancer drugs in people with urothelial cancer or KRAS-mutant non-small cell lung cancer.
-
SI-B036 safety test in advanced and metastatic solid tumors
This early-phase study checks whether SI-B036 is safe and tolerable in adults with advanced or metastatic solid cancers who have had prior therapy.
-
Postoperative EGFR-TKI Therapy for EGFR-mutant NSCLC Following Surgery
This registry tests whether giving an EGFR-TKI after surgery helps adults with EGFR-mutant, high-risk early-stage NSCLC.
-
HS-20093 with Adebrelimab vs HS-20093 alone in advanced non-squamous NSCLC
This study tests whether adding adebrelimab to HS-20093 helps patients with advanced non-squamous NSCLC who have already had treatment.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.