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

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ClinicalTrials.gov Identifier: NCT04806412
Recruitment Status : Recruiting
First Posted : March 19, 2021
Last Update Posted : July 12, 2021
Sponsor:
Information provided by (Responsible Party):
Naestved Hospital

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Malignant Pleural Effusion Non-small Cell Lung Cancer Diagnostic Test: meassurement of PD-L1, ALK, EGFR Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: prospective, non-randomized, cohort study
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Prevalence of Oncodrivers in Malignant Pleural Effusions Associated With Non-small Cell Lung Cancer: A Prospective Study.
Actual Study Start Date : March 15, 2021
Estimated Primary Completion Date : March 12, 2023
Estimated Study Completion Date : May 12, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer


Intervention Details:
  • Diagnostic Test: meassurement of PD-L1, ALK, EGFR

    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 Outcome Measures :
  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 Outcome Measures :
  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 after thoracentesis [ Time Frame: at day 1, 10 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04806412


Contacts
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Contact: Katrine Fjaellegaard, MD 31924375 kafj@regionsjaelland.dk

Locations
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Denmark
Næstved Sygehus, department of pulmonary medicine Recruiting
Næstved, Region Sjælland, Denmark, 4700
Contact: katrine fjællegaard, MD    20864959    kafj@regionsjaelland.dk   
Contact: Uffe Bødtger, MD, PhD         
Sponsors and Collaborators
Naestved Hospital
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Responsible Party: Naestved Hospital
ClinicalTrials.gov Identifier: NCT04806412    
Other Study ID Numbers: SJ-889
First Posted: March 19, 2021    Key Record Dates
Last Update Posted: July 12, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Pleural Effusion, Malignant
Pleural Effusion
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Pleural Diseases
Pleural Neoplasms