Oncodrivers in Malignant Pleural Effusions Associated With Non-small Cell Lung Cancer: A Prospective Study.
Primary Purpose
Malignant Pleural Effusion, Non-small Cell Lung Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
meassurement of PD-L1, ALK, EGFR
Sponsored by
About this trial
This is an interventional diagnostic trial for Malignant Pleural Effusion
Eligibility 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.
Sites / Locations
- Næstved Sygehus, department of pulmonary medicineRecruiting
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Proportion of adequate and inadequate pleural fluid specimens
Amounts of pleural fluid sent for analysis
Meassured in mL.
Correlation between amounts of pleural fluid sent to the pathologist and the chance of obtaining oncodriver status
Number and type of additional diagnostic interventions including additional thoracentesis and cytological or histological biopsies
Prevalence of oncodriver status in additional diagnostic interventions
- Correlation between oncodriver status obtained in pleural fluid specimens and cytological or histological biopsies
- 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
- Proportion of work-ups where full oncodriver-status was obtained at the second thoracentesis
- Proportion of patients with pleural fluid cytology negative of NSCLC, who is diagnosed with NSCLC.
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)
Proportion of patients experiencing pneumothorax
Proportion of patients experiencing bleeding
Proportion of complications leading to admission
assessed by evaluating the patient file
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04806412
Brief Title
Oncodrivers in Malignant Pleural Effusions Associated With Non-small Cell Lung Cancer: A Prospective Study.
Official Title
The Prevalence of Oncodrivers in Malignant Pleural Effusions Associated With Non-small Cell Lung Cancer: A Prospective Study.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2021 (Actual)
Primary Completion Date
March 12, 2023 (Anticipated)
Study Completion Date
May 12, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Naestved Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Pleural Effusion, Non-small Cell Lung Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
prospective, non-randomized, cohort study
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Diagnostic Test
Intervention Name(s)
meassurement of PD-L1, ALK, EGFR
Intervention Description
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 Measure Information:
Title
Prevalence of oncodriver status
Description
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
Time Frame
assessed at 8 weeks follow-up
Secondary Outcome Measure Information:
Title
Proportion of adequate and inadequate pleural fluid specimens
Time Frame
assessed at 8-week follow-up
Title
Amounts of pleural fluid sent for analysis
Description
Meassured in mL.
Time Frame
assessed at 8-week follow-up
Title
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
Title
Number and type of additional diagnostic interventions including additional thoracentesis and cytological or histological biopsies
Time Frame
assessed at 8-week follow-up
Title
Prevalence of oncodriver status in additional diagnostic interventions
Time Frame
assessed at 8-week follow-up
Title
- Correlation between oncodriver status obtained in pleural fluid specimens and cytological or histological biopsies
Time Frame
assessed at 8-week follow-up
Title
- 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
Title
- Proportion of work-ups where full oncodriver-status was obtained at the second thoracentesis
Time Frame
assessed at 8-week follow-up
Title
- Proportion of patients with pleural fluid cytology negative of NSCLC, who is diagnosed with NSCLC.
Time Frame
assessed at 8-week follow-up
Title
Patient assessed pain during thoracentesis
Description
assessed by a questionnaire containing a VAS (Visual Analogue Scale, scale 0-10, 0 being no pain, 10 being the worse pain)
Time Frame
at day 1, 2 minutes after thoracentesis
Title
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
Title
Proportion of patients experiencing bleeding
Time Frame
assessed at day 1, 10 minutes after thoracentesis and 8-week follow-up
Title
Proportion of complications leading to admission
Description
assessed by evaluating the patient file
Time Frame
assessed at 8-week follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katrine Fjaellegaard, MD
Phone
31924375
Email
kafj@regionsjaelland.dk
Facility Information:
Facility Name
Næstved Sygehus, department of pulmonary medicine
City
Næstved
State/Province
Region Sjælland
ZIP/Postal Code
4700
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
katrine fjællegaard, MD
Phone
20864959
Email
kafj@regionsjaelland.dk
First Name & Middle Initial & Last Name & Degree
Uffe Bødtger, MD, PhD
12. IPD Sharing Statement
Learn more about this trial
Oncodrivers in Malignant Pleural Effusions Associated With Non-small Cell Lung Cancer: A Prospective Study.
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