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NCT Number: NCT04806412

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.

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Key information

Conditions

Malignant Pleural Effusion Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Non-small Cell Lung Cancer Pleural Diseases Pleural Effusion Pleural Effusion, Malignant Pleural Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Næstved Sygehus, department of pulmonary medicine

Næstved, Region Sjælland, 4700, Denmark

Location status: Recruiting

Location contact

Uffe Bødtger, MD, PhD

CONTACT

katrine fjællegaard, MD

CONTACT

[email protected]

20864959

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

meassurement of PD-L1, ALK, EGFR

Diagnostic 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)

Primary outcomes

  1. 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

Secondary outcomes

  1. Proportion of adequate and inadequate pleural fluid specimens

    Time frame: assessed at 8-week follow-up

  2. Amounts of pleural fluid sent for analysis

    Time frame: assessed at 8-week follow-up

    Meassured in mL.

  3. 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

  4. Number and type of additional diagnostic interventions including additional thoracentesis and cytological or histological biopsies

    Time frame: assessed at 8-week follow-up

  5. Prevalence of oncodriver status in additional diagnostic interventions

    Time frame: assessed at 8-week follow-up

  6. - Correlation between oncodriver status obtained in pleural fluid specimens and cytological or histological biopsies

    Time frame: assessed at 8-week follow-up

  7. - 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

  8. - Proportion of work-ups where full oncodriver-status was obtained at the second thoracentesis

    Time frame: assessed at 8-week follow-up

  9. - Proportion of patients with pleural fluid cytology negative of NSCLC, who is diagnosed with NSCLC.

    Time frame: assessed at 8-week follow-up

  10. Patient assessed pain during thoracentesis

    Time frame: at day 1, 2 minutes after thoracentesis

    assessed by a questionnaire containing a VAS (Visual Analogue Scale, scale 0-10, 0 being no pain, 10 being the worse pain)

  11. 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

  12. Proportion of patients experiencing bleeding

    Time frame: assessed at day 1, 10 minutes after thoracentesis and 8-week follow-up

  13. Proportion of complications leading to admission

    Time frame: assessed at 8-week follow-up

    assessed by evaluating the patient file

Study contacts

Contact information is provided by the study sponsor or research team.

Katrine Fjaellegaard, MD

CONTACT

[email protected]

31924375

Sponsors and collaborators

Lead sponsor

Naestved Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
Mar 19, 2021
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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