Malignant Pleural EffusionNCT04806412
Oncodrivers in Malignant Pleural Effusions Associated With Non-small Cell Lung Cancer: A Prospective Study.
A study testing meassurement of PD-L1, ALK, EGFR in people with Malignant Pleural Effusion and Non-small Cell Lung Cancer, run by Naestved Hospital at 1 site in Denmark.
Trial summary
Oncological treatment of patients with disseminated non-small cell lung cancer (NSCLC) is depending on the status of programmed death-ligand 1 (PD-L1), anaplastic lymphoma kinase (ALK) and epidermal growth factor receptor (EGFR), so called oncodrivers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Pleural Effusion, Non-small Cell Lung Cancer
- What is being tested?
- meassurement of PD-L1, ALK, EGFR
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Mar 2021to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Full oncodriver status measured in any pleural fluid in current work-up
- Inability to understand written or spoken Danish.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Næstved Sygehus, department of pulmonary medicine
Næstved, Region Sjælland, 4700
katrine fjællegaard, MD, 20864959, kafj@regionsjaelland.dk
Uffe Bødtger, MD, PhD
About this study
Official title: The Prevalence of Oncodrivers in Malignant Pleural Effusions Associated With Non-small Cell Lung Cancer: A Prospective Study.
Oncological treatment of patients with disseminated non-small cell lung cancer (NSCLC) is depending on the status of programmed death-ligand 1 (PD-L1), anaplastic lymphoma kinase (ALK) and epidermal growth factor receptor (EGFR), so called oncodrivers. These can be measured in pleural fluid, but the prevalence is uncertain. In a prospective study, the research team aim to measure PD-L1, ALK and EGFR in patients with pleural fluid cytology positive for NSCLC to report the prevalence. Also, the study will investigate if the chance of obtaining oncodriver status is depending on the volume analysed and how the lack of oncodrivers influence the following work-up.
Read the detailed description
The study is a prospective, non-randomized, cohort study of patients with pleural effusion. Participants will be recruited from patients referred to the Pleura Clinic or admitted at the ward at the Department of Respiratory Medicine, Næstved Hospital, Næstved or at the Department of Respiratory Medicine, Zealand University Hospital, Roskilde, which is the two regional centres for workup of pleural effusions. Patients will be referred from either general practice or other hospital departments.
Pleural fluids with cytology positive for NSCLC will be tested for oncodrivers (for squamous cell carcinomas (SCC): PD-L1, for adenocarcinomas (AC): PD-L1, ALK and EGFR).
Follow-up will be 8 weeks after inclusion.
- Being tested
- meassurement of PD-L1, ALK, EGFR
- Medical subject headings
- Pleural Effusion, Malignant, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
meassurement of PD-L1, ALK, EGFRDiagnostic test
PD-L1 test will be performed on cell-blocks using PD-L1 antibodies 22C3 and staining platform Dako Omnis (Agilent, Glostrup -Denmark).
ALK test will be performed on cell-blocks using staining platform Dako Omnis (Agilent, Glostrup- Denmark) and ALK antibodies "Origene" clone: OT1A4. Sample quality is assessed as for PD-L1.
EGFR mutation analysis will be performed as follows: after tumor content evaluation of hematoxylin and eosin stained slides, relevant regions are macrodissected and subjected to a standard genomic DNA extraction procedure using the GeneRead DNA FFPE Kit (Qiagen). Samples will be analysed using the GeneRead QIAact Actionable Insights Tumor Panel (Qiagen)
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of oncodriver status
Prevalence of oncodriver status (for squamous cell carcinomas (SCC): PD-L1, for adenocarcinomas (AC): PD-L1, ALK and EGFR) in pleural fluid in patients with cytology positive for pulmonary NSCLC
Measured: assessed at 8 weeks follow-up
Secondary outcomes (13)
Proportion of adequate and inadequate pleural fluid specimens
Measured: assessed at 8-week follow-up
Amounts of pleural fluid sent for analysis
Meassured in mL.
Measured: assessed at 8-week follow-up
Correlation between amounts of pleural fluid sent to the pathologist and the chance of obtaining oncodriver status
Measured: assessed at 8-week follow-up
Number and type of additional diagnostic interventions including additional thoracentesis and cytological or histological biopsies
Measured: assessed at 8-week follow-up
Prevalence of oncodriver status in additional diagnostic interventions
Measured: assessed at 8-week follow-up
- Correlation between oncodriver status obtained in pleural fluid specimens and cytological or histological biopsies
Measured: assessed at 8-week follow-up
- Proportion of work-ups where the lack of obtained oncodriver status in pleural fluid specimens leads to additional diagnostic interventions including additional thoracentesis and cytological or histological biopsies
Measured: assessed at 8-week follow-up
- Proportion of work-ups where full oncodriver-status was obtained at the second thoracentesis
Measured: assessed at 8-week follow-up
- Proportion of patients with pleural fluid cytology negative of NSCLC, who is diagnosed with NSCLC.
Measured: assessed at 8-week follow-up
Patient assessed pain during thoracentesis
assessed by a questionnaire containing a VAS (Visual Analogue Scale, scale 0-10, 0 being no pain, 10 being the worse pain)
Measured: at day 1, 2 minutes after thoracentesis
Proportion of patients experiencing pneumothorax
Measured: assessed at day 1, 10 minutes after thoracentesis and 8-week follow-up by evaluating the patient file
Proportion of patients experiencing bleeding
Measured: assessed at day 1, 10 minutes after thoracentesis and 8-week follow-up
Proportion of complications leading to admission
assessed by evaluating the patient file
Measured: assessed at 8-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start15 Mar 2021
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Pleural EffusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- prospective, non-randomized, cohort study
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Naestved Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04806412
- Sponsor's protocol ID
- SJ-889
- Status last verified
- Dec 2025
- First submitted
- 16 Mar 2021
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of Oncodrivers in Malignant Pleural Effusions Associated With Non-small Cell Lung Cancer: A Prospective Study.
- ClinicalTrials.gov ID
- NCT04806412
- Acronym / sponsor ID
- SJ-889
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Naestved HospitalUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 19 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Oncological treatment of patients with disseminated non-small cell lung cancer (NSCLC) is depending on the status of programmed death-ligand 1 (PD-L1), anaplastic lymphoma kinase (ALK) and epidermal growth factor receptor (EGFR), so called oncodrivers. These can be measured in pleural fluid, but the prevalence is uncertain. In a prospective study, the research team aim to measure PD-L1, ALK and EGFR in patients with pleural fluid cytology positive for NSCLC to report the prevalence. Also, the study will investigate if the chance of obtaining oncodriver status is depending on the volume analysed and how the lack of oncodrivers influence the following work-up.
Detailed description
The study is a prospective, non-randomized, cohort study of patients with pleural effusion. Participants will be recruited from patients referred to the Pleura Clinic or admitted at the ward at the Department of Respiratory Medicine, Næstved Hospital, Næstved or at the Department of Respiratory Medicine, Zealand University Hospital, Roskilde, which is the two regional centres for workup of pleural effusions. Patients will be referred from either general practice or other hospital departments.
Pleural fluids with cytology positive for NSCLC will be tested for oncodrivers (for squamous cell carcinomas (SCC): PD-L1, for adenocarcinomas (AC): PD-L1, ALK and EGFR).
Follow-up will be 8 weeks after inclusion.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- prospective, non-randomized, cohort study
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Full oncodriver status measured in any pleural fluid in current work-up
- Inability to understand written or spoken Danish.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| meassurement of PD-L1, ALK, EGFRPD-L1 test will be performed on cell-blocks using PD-L1 antibodies 22C3 and staining platform Dako Omnis (Agilent, Glostrup -Denmark). ALK test will be performed on cell-blocks using staining platform Dako Omnis (Agilent, Glostrup- Denmark) and ALK antibodies "Origene" clone: OT1A4. Sample quality is assessed as for PD-L1. EGFR mutation analysis will be performed as follows: after tumor content evaluation of hematoxylin and eosin stained slides, relevant regions are macrodissected and subjected to a standard genomic DNA extraction procedure using the GeneRead DNA FFPE Kit (Qiagen). Samples will be analysed using the GeneRead QIAact Actionable Insights Tumor Panel (Qiagen) | Diagnostic test | – |
Primary outcome
Prevalence of oncodriver status
Time frame: assessed at 8 weeks follow-up
Prevalence of oncodriver status (for squamous cell carcinomas (SCC): PD-L1, for adenocarcinomas (AC): PD-L1, ALK and EGFR) in pleural fluid in patients with cytology positive for pulmonary NSCLC
13 secondary outcomes
Proportion of adequate and inadequate pleural fluid specimens
Time frame: assessed at 8-week follow-up
Amounts of pleural fluid sent for analysis
Time frame: assessed at 8-week follow-up
Correlation between amounts of pleural fluid sent to the pathologist and the chance of obtaining oncodriver status
Time frame: assessed at 8-week follow-up
Number and type of additional diagnostic interventions including additional thoracentesis and cytological or histological biopsies
Time frame: assessed at 8-week follow-up
Prevalence of oncodriver status in additional diagnostic interventions
Time frame: assessed at 8-week follow-up
- Correlation between oncodriver status obtained in pleural fluid specimens and cytological or histological biopsies
Time frame: assessed at 8-week follow-up
- Proportion of work-ups where the lack of obtained oncodriver status in pleural fluid specimens leads to additional diagnostic interventions including additional thoracentesis and cytological or histological biopsies
Time frame: assessed at 8-week follow-up
- Proportion of work-ups where full oncodriver-status was obtained at the second thoracentesis
Time frame: assessed at 8-week follow-up
- Proportion of patients with pleural fluid cytology negative of NSCLC, who is diagnosed with NSCLC.
Time frame: assessed at 8-week follow-up
Patient assessed pain during thoracentesis
Time frame: at day 1, 2 minutes after thoracentesis
Proportion of patients experiencing pneumothorax
Time frame: assessed at day 1, 10 minutes after thoracentesis and 8-week follow-up by evaluating the patient file
Proportion of patients experiencing bleeding
Time frame: assessed at day 1, 10 minutes after thoracentesis and 8-week follow-up
Proportion of complications leading to admission
Time frame: assessed at 8-week follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing meassurement of PD-L1, ALK, EGFR in people with Malignant Pleural Effusion and Non-small Cell Lung Cancer, run by Naestved Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katrine Fjaellegaard, MD (31924375, kafj@regionsjaelland.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of oncodriver status (time frame: assessed at 8 weeks follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.