The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04806412
Recruitment Status : Unknown
Verified May 2022 by Naestved Hospital.
Recruitment status was:  Recruiting
First Posted : March 19, 2021
Last Update Posted : May 17, 2022
Sponsor:
Information provided by (Responsible Party):
Naestved Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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)


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location contacts
Contact: Katrine Fjaellegaard, MD 31924375 kafj@regionsjaelland.dk

Locations
Layout table for location information
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
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
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: May 17, 2022
Last Verified: May 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
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